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 Critical Jul 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Devices Critical Jul 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Devices Critical Jul 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Devices Critical Jul 21, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Devices Moderate Jul 14, 2021

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Devices Moderate Jul 14, 2021

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
FDA Devices Moderate Jul 14, 2021

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
FDA Devices Moderate Jul 14, 2021

Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
FDA Devices Moderate Jul 14, 2021

VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
FDA Devices Moderate Jul 14, 2021

Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
FDA Devices Critical May 26, 2021

VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
FDA Devices Critical May 26, 2021

VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
FDA Devices Moderate May 26, 2021

ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion lengths up to 190 mm.
FDA Devices Moderate May 5, 2021

UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton.

FDA Devices Moderate May 5, 2021

Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
FDA Devices Low May 5, 2021

EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
FDA Devices Moderate Apr 28, 2021

The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number
FDA Devices Moderate Apr 21, 2021

MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
FDA Devices Moderate Apr 21, 2021

MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
FDA Devices Moderate Mar 10, 2021

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.
FDA Devices Moderate Mar 10, 2021

Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.
FDA Devices Moderate Mar 10, 2021

Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
FDA Devices Critical Feb 17, 2021

EMBLEM S-ICD Model A209
FDA Devices Critical Feb 17, 2021

EMBLEM MRI S-ICD Model A219
FDA Devices Moderate Feb 3, 2021

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Devices Moderate Feb 3, 2021

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Devices Critical Jan 27, 2021

EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
FDA Devices Moderate Jan 27, 2021

ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Devices Moderate Jan 13, 2021

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Devices Moderate Jan 13, 2021

AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Devices Moderate Jan 13, 2021

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Devices Moderate Jan 13, 2021

AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Devices Moderate Jan 13, 2021

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Devices Moderate Jan 13, 2021

AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Devices Moderate Jan 6, 2021

Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
FDA Devices Moderate Jan 6, 2021

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
FDA Devices Moderate Dec 30, 2020

IceSeed" 1.5 Cryoablation Needle
FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 CX 90¿ Cryoablation Needle¿
FDA Devices Moderate Dec 30, 2020

Five IceSphere" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX Cryoablation Needle
FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 i-Thaw" Cryoablation Needle
FDA Devices Moderate Dec 30, 2020

IceSeed" 1.5 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020

IceSeed" 1.5 MRI Cryoablation Needle

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