PlainRecalls

Boston Scientific Corporation

Compiled from official public sources by the publisher.

632 recalls on record · Latest: Aug 12, 2026

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Agency notice ledger

Federal filing book Boston Scientific Corporati… HEAVY-BOOK · SINGLE-AGENCY

#10 of 14,151 · 632 notices · 0.605% archive

  • BOOK 632 notices
  • RANK #10 of 14,151
  • SHARE 0.605% archive
  • AGENCY FDA Devices (632)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 12, 2026
  • PHOTO Garden Fresh Foods, I…

Nearest notice-volume peer: Garden Fresh Foods, Inc. (2 notice gap)

Boston Scientific Corporation sits #10 of 14,151 (10th among 14,151 firms) with 632 federal notices — about 0.605% of the archive (heavy-book tercile). Rank counts issuance frequency, not danger. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Boston Scientific Corporati… sits among 14,151 recalling firms

Boston Scientific Corporation ranks 10th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Boston Scientific Corporati… vs all firms by recall-notice count

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

632 10th of 14151 higher than 14,141 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

Boston Scientific Corporati… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Boston Scientific Corporation carries 632 distinct federal notices, ranked #10 of 14,151 (heavy-book).

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Aug 12, 2026

Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
FDA Devices Moderate Aug 12, 2026

Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240c
FDA Devices Moderate Aug 12, 2026

Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.
FDA Devices Moderate Jul 29, 2026

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
FDA Devices Moderate Jul 29, 2026

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
FDA Devices Moderate Jul 29, 2026

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
FDA Devices Moderate Jul 29, 2026

FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
FDA Devices Moderate Jul 29, 2026

FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
FDA Devices Moderate Jul 29, 2026

Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
FDA Devices Moderate Jul 29, 2026

FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
FDA Devices Moderate Jul 29, 2026

FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
FDA Devices Moderate Jul 29, 2026

FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
FDA Devices Moderate Jul 22, 2026

Rapid Refill Continuous Injection System, UPN M00566001
FDA Devices Moderate Jul 8, 2026

CRE Pro Wireguided 12-15mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Pro Wireguided 10-12mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Pro Wireguided 15-18mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Pro Wireguided 6-8mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Wireguided 8-10mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Wireguided 12-15mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Wireguided 15-18mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Wireguided 6-8mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Wireguided 18-20mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Pro Wireguided 8-10mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Wireguided 10-12mm 240cm
FDA Devices Moderate Jul 8, 2026

CRE Pro Wireguided 18-20mm 240cm
FDA Devices Moderate Jul 1, 2026

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
FDA Devices Moderate Jun 17, 2026

Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
FDA Devices Moderate May 13, 2026

LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
FDA Devices Moderate May 13, 2026

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Devices Critical May 6, 2026

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.
FDA Devices Critical May 6, 2026

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pac
FDA Devices Moderate Mar 18, 2026

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
FDA Devices Critical Feb 11, 2026

HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
FDA Devices Critical Feb 11, 2026

AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
FDA Devices Critical Feb 11, 2026

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
FDA Devices Critical Feb 11, 2026

AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
FDA Devices Critical Feb 11, 2026

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
FDA Devices Critical Feb 11, 2026

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
FDA Devices Moderate Jan 21, 2026

Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
FDA Devices Critical Oct 22, 2025

Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Devices Critical Oct 22, 2025

Model Number S702, ALTRUA 2 DR SL Pacemaker
FDA Devices Critical Oct 22, 2025

Model Number U128, VALITUDE CRT-P EL MRI
FDA Devices Critical Oct 22, 2025

Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Devices Moderate Oct 22, 2025

TENACIO Pump without InhibiZone; UPN: 72404420;
FDA Devices Critical Oct 22, 2025

Model Number L101, ESSENTIO DR SL Pacemaker
FDA Devices Critical Oct 22, 2025

Model Number L209 PROPONENT DR (VDD) SL Pacemaker
FDA Devices Critical Oct 22, 2025

Model Number U226, VISIONIST CRT-P EL
FDA Devices Moderate Oct 22, 2025

TENACIO Pump with InhibiZone; UPN: 72404429;
FDA Devices Critical Oct 22, 2025

PROPONENT SR SL (Model L200)
FDA Devices Critical Oct 22, 2025

Model Number U228, VISIONIST CRT-P EL MRI

Boston Scientific Corporati… sits in the heavy federal notice book

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

Similar recall count

Nearest multi-notice firms by distinct-event totals (632 here — heavy-book).

Garden Fresh Foods, Inc. 634 Icu Medical, Inc. 657 Newly Weds Foods, Inc. 657 Siemens Healthcare Diagnostics, Inc. 665 Customed, Inc 682

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Icu Medical, Inc. 657 Siemens Healthcare Diagnostics, Inc. 665 Customed, Inc 682 Medline Industries, LP 486

Frequently Asked Questions

How many federal recall notices name Boston Scientific Corporati…? ▼
PlainRecalls indexes 632 distinct federal recall events naming Boston Scientific Corporation, 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 Boston Scientific Corporati… sit among other recalling firms? ▼
Boston Scientific Corporation ranks #10 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 Boston Scientific Corporati…'s notices? ▼
FDA Devices accounts for 632 of this firm's 632 indexed notices.
What product category dominates Boston Scientific Corporati…'s filing book? ▼
Filings for Boston Scientific Corporation 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.
Boston Scientific Corporation: 632 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 Boston Scientific Corporation; individual notices remain authoritative on each linked recall page.

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