PlainRecalls

Boston Scientific Corporation

413 recalls on record · Latest: Feb 11, 2026

Boston Scientific Corporation Recall Insight

Boston Scientific Corporation appears on 413 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.492% 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 Feb 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 5 critical, 45 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 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 (50). The date window on this page runs from Jan 22, 2014 to Jan 24, 2018.

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 Jan 24, 2018

ESSENTIO MRI SR Pacemaker

FDA Devices Moderate Jan 24, 2018

ESSENTIO MRI EL DR Pacemaker

FDA Devices Moderate Jan 24, 2018

ACCOLADE EL DR Pacemaker

FDA Devices Moderate Nov 15, 2017

RESONATE X4 CRT-D, Model G447, Sterile.

FDA Devices Moderate Nov 15, 2017

RESONATE EL ICD VR, Model D432, Sterile.

FDA Devices Moderate Nov 15, 2017

MOMENTUM X4 CRT-D, Model G138, Sterile.

FDA Devices Moderate Nov 15, 2017

RESONATE EL ICD DR, Model D433, Sterile.

FDA Devices Moderate Nov 15, 2017

VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure …

FDA Devices Moderate Sep 20, 2017

FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pre…

FDA Devices Moderate Aug 23, 2017

SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threaten…

FDA Devices Moderate Aug 23, 2017

EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide d…

FDA Devices Moderate Aug 23, 2017

EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defib…

FDA Devices Moderate Jul 12, 2017

Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pa…

FDA Devices Moderate Jul 12, 2017

Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340

FDA Devices Moderate May 10, 2017

The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. …

FDA Devices Moderate Apr 19, 2017

Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)

FDA Devices Moderate Mar 15, 2017

AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the T…

FDA Devices Moderate Feb 15, 2017

Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.

FDA Devices Moderate Jan 11, 2017

Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.

FDA Devices Moderate May 4, 2016

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanentl…

FDA Devices Critical Apr 27, 2016

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of f…

FDA Devices Moderate Apr 20, 2016

Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UP…

FDA Devices Moderate Jan 20, 2016

Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as n…

FDA Devices Moderate Jan 13, 2016

Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116…

FDA Devices Critical Dec 30, 2015

Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 4…

FDA Devices Critical Nov 18, 2015

RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (sin…

FDA Devices Critical Nov 18, 2015

RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H8022333…

FDA Devices Moderate Nov 18, 2015

Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.

FDA Devices Moderate Sep 23, 2015

Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU…

FDA Devices Moderate Sep 23, 2015

Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU200…

FDA Devices Moderate Aug 19, 2015

AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. …

FDA Devices Moderate Aug 19, 2015

AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. …

FDA Devices Moderate Aug 19, 2015

AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. F…

FDA Devices Moderate Jul 8, 2015

Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX …

FDA Devices Moderate Jun 24, 2015

CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as…

FDA Devices Moderate Apr 8, 2015

Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits

FDA Devices Moderate Apr 8, 2015

Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD…

FDA Devices Critical Jan 21, 2015

Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; …

FDA Devices Moderate Oct 15, 2014

StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455

FDA Devices Moderate Jun 25, 2014

IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conj…

FDA Devices Moderate Jun 25, 2014

IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in co…

FDA Devices Moderate Jun 25, 2014

IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in …

FDA Devices Moderate Jun 25, 2014

IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in co…

FDA Devices Moderate Apr 30, 2014

iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.

FDA Devices Moderate Mar 19, 2014

Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.

FDA Devices Moderate Feb 19, 2014

Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.

FDA Devices Moderate Jan 22, 2014

TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific…

FDA Devices Moderate Jan 22, 2014

Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter …

FDA Devices Moderate Jan 22, 2014

TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign…

FDA Devices Moderate Jan 22, 2014

TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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