PlainRecalls

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

Compiled from official public sources by the editorial team.

198 recalls on record · Latest: Jun 28, 2023

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

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) appears on 198 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.195% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jun 28, 2023, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 48 entries, severity tagging shows 15 critical, 32 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 48 of 48 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (48). The date window on this page runs from Feb 28, 2018 to Jul 15, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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

CareLink SmartSync Device Manager, Model Number 24970A

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

Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

FDA Devices Moderate Mar 25, 2020

Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

FDA Devices Moderate Nov 6, 2019

Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer

FDA Devices Moderate Nov 6, 2019

Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager

FDA Devices Moderate Nov 6, 2019

Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer

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 us…

FDA Devices Moderate Feb 27, 2019

Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer

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 REVD…

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) Mode…

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 …

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 SED…

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 ADD…

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 N…

FDA Devices Moderate Feb 13, 2019

MEDTRONIC CARELINK 2090 programmer

FDA Devices Moderate Feb 13, 2019

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

FDA Devices Moderate Nov 14, 2018

Medtronic CareLink Encore 29901 Programmer

FDA Devices Moderate Nov 14, 2018

Medtronic CareLink 2090 Programmer

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 (…

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 ther…

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 ther…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Produ…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular a…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Prod…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Produ…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Prod…

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 (…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular a…

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. Ever…

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 …

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…

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. …

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); …

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); …

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); …

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); …

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.