PlainRecalls

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

198 recalls on record · Latest: Jun 28, 2023

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Agency notice ledger

Federal filing book Medtronic Inc., Cardiac Rhy… HEAVY-BOOK · SINGLE-AGENCY

#73 of 14,151 · 198 notices · 0.190% archive

  • BOOK 198 notices
  • RANK #73 of 14,151
  • SHARE 0.190% archive
  • AGENCY FDA Devices (198)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jun 28, 2023
  • PHOTO Franck's Lab Inc., d.…

Nearest notice-volume peer: Franck's Lab Inc., d.b.a. Franck's Compounding Lab (0 notice gap)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) accounts for about 0.190% of the 104,423-notice archive on 198 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Medtronic Inc., Cardiac Rhy… sits among 14,151 recalling firms

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ranks 73rd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Medtronic Inc., Cardiac Rhy… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

198 73rd of 14151 higher than 14,078 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Medtronic Inc., Cardiac Rhy… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) holds about 0.190% of archive notices alongside 198 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 15, 2020

Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04

FDA Devices Moderate Jul 15, 2020
FDA Devices Moderate Jul 15, 2020

Azure S DR MRI, Model Number W3DR01

FDA Devices Moderate Jul 15, 2020

Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01

FDA Devices Moderate Jul 15, 2020

Azure S SR MRI, Model Number W3SR01

FDA Devices Moderate Jul 15, 2020

Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01

FDA Devices Moderate Jul 15, 2020

Patient Connector, Model Number 24967

FDA Devices Moderate Jul 15, 2020

Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05

FDA Devices Moderate Jul 15, 2020

Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06

FDA Devices Moderate Mar 25, 2020
FDA Devices Moderate Mar 25, 2020
FDA Devices Moderate Nov 6, 2019
FDA Devices Moderate Nov 6, 2019
FDA Devices Moderate Nov 6, 2019
FDA Devices Moderate Sep 18, 2019

Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.

FDA Devices Moderate Sep 18, 2019

Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.

FDA Devices Low Apr 3, 2019

Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of t

FDA Devices Moderate Feb 27, 2019
FDA Devices Critical Feb 20, 2019

Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01

FDA Devices Critical Feb 20, 2019

Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1

FDA Devices Critical Feb 20, 2019

vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2

FDA Devices Critical Feb 20, 2019

Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1

FDA Devices Critical Feb 20, 2019

Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01

FDA Devices Critical Feb 20, 2019

Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01

FDA Devices Critical Feb 20, 2019

Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1

FDA Devices Moderate Feb 13, 2019
FDA Devices Moderate Feb 13, 2019
FDA Devices Moderate Nov 14, 2018
FDA Devices Moderate Nov 14, 2018
FDA Devices Moderate Jul 18, 2018

Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

FDA Devices Moderate Jul 18, 2018

Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

FDA Devices Moderate Jul 18, 2018

Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhyth

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhyth

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

FDA Devices Moderate Jul 18, 2018

Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

FDA Devices Moderate Jul 4, 2018

Single Chamber Temporary External Pacemaker, Model 53401

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e. Evera MRI S DR ICD DF4 (Product No. DDMC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricu

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DVBB1D1); f. Evera XT VR ICD DF4 (Product No. DVBB1D4); EXPANSION: g. Evera S DR ICD DF4 (Product No. DDBC3D4); h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); i. Ever

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4)

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1); d. Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia,

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some d

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some

Medtronic Inc., Cardiac Rhy… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Medtronic Inc., Cardiac Rhy…?
PlainRecalls indexes 198 distinct federal recall events naming Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Medtronic Inc., Cardiac Rhy… sit among other recalling firms?
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ranks #73 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Medtronic Inc., Cardiac Rhy…'s notices?
FDA Devices accounts for 198 of this firm's 198 indexed notices.
What product category dominates Medtronic Inc., Cardiac Rhy…'s filing book?
Filings for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): 198 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026