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 0 critical, 47 moderate, and 3 lower-severity recalls. Affected-unit counts are disclosed on 47 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 24, 2018 to Dec 4, 2019.

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 Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690

FDA Devices Moderate Dec 4, 2019

Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640

FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650

FDA Devices Moderate Dec 4, 2019

Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; …

FDA Devices Moderate Sep 25, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Devices Moderate Sep 25, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

FDA Devices Moderate Sep 11, 2019

AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161

FDA Devices Moderate May 29, 2019

AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a …

FDA Devices Moderate May 29, 2019

AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including …

FDA Devices Moderate May 29, 2019

AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a …

FDA Devices Moderate May 29, 2019

AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic…

FDA Devices Moderate May 29, 2019

AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber opti…

FDA Devices Moderate May 29, 2019

AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fi…

FDA Devices Moderate Mar 20, 2019

Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210

FDA Devices Moderate Mar 20, 2019

Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220

FDA Devices Low Jan 16, 2019

IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF…

FDA Devices Low Jan 16, 2019

Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF)…

FDA Devices Low Jan 16, 2019

IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF…

FDA Devices Moderate Oct 31, 2018

Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z…

FDA Devices Moderate Oct 3, 2018

VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

FDA Devices Moderate Oct 3, 2018

PROPONENT Pacemaker

FDA Devices Moderate Oct 3, 2018

ACCOLADE Pacemaker

FDA Devices Moderate Aug 15, 2018

Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which …

FDA Devices Moderate May 16, 2018

Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture …

FDA Devices Moderate May 16, 2018

Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to a…

FDA Devices Moderate May 16, 2018

PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

FDA Devices Moderate May 16, 2018

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

FDA Devices Moderate May 16, 2018

PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

FDA Devices Moderate Mar 28, 2018

Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutan…

FDA Devices Moderate Mar 28, 2018

Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to…

FDA Devices Moderate Mar 28, 2018

Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish…

FDA Devices Moderate Mar 28, 2018

SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

FDA Devices Moderate Mar 28, 2018

Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed…

FDA Devices Moderate Mar 14, 2018

Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.

FDA Devices Moderate Mar 14, 2018

Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.

FDA Devices Moderate Feb 28, 2018

Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Exp…

FDA Devices Moderate Jan 24, 2018

PROPONENT SR Pacemaker

FDA Devices Moderate Jan 24, 2018

ACCOLADE DR Pacemaker

FDA Devices Moderate Jan 24, 2018

ACCOLADE SR Pacemaker

FDA Devices Moderate Jan 24, 2018

VISIONIST CRT-P Pacemaker

FDA Devices Moderate Jan 24, 2018

ESSENTIO DR Pacemaker

FDA Devices Moderate Jan 24, 2018

ALTRUA 2 EL DR Pacemaker

FDA Devices Moderate Jan 24, 2018

ACCOLADE MRI EL DR Pacemaker

FDA Devices Moderate Jan 24, 2018

PROPONENT DR Pacemaker

FDA Devices Moderate Jan 24, 2018

VALITUDE CRT-P Pacemaker

FDA Devices Moderate Jan 24, 2018

PROPONENT EL DR Pacemaker

FDA Devices Moderate Jan 24, 2018

ACCOLADE MRI DR Pacemaker

FDA Devices Moderate Jan 24, 2018

ACCOLADE MRI SR Pacemaker

FDA Devices Moderate Jan 24, 2018

ESSENTIO SR Pacemaker

FDA Devices Moderate Jan 24, 2018

ALTRUA 2 SR Pacemaker

Nearby Manufacturers

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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