Boston Scientific Corporation
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
- Customed, Inc
Customed, Inc
682 notices
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Siemens Healthcare Diagnostics, Inc.
665 notices
- Icu Medical,…
Icu Medical, Inc.
657 notices
- Newly Weds Fo…
Newly Weds Foods, Inc.
657 notices
- Garden Fresh…
Garden Fresh Foods, Inc.
634 notices
- Boston Scient… (this)
Boston Scientific Corporation
632 notices
What this shows Boston Scientific Corporation carries 632 distinct federal notices, ranked #10 of 14,151 (heavy-book).
FDA Devices Moderate Oct 3, 2018
PROPONENT Pacemaker
FDA Devices Moderate Oct 3, 2018
ACCOLADE Pacemaker
FDA Devices Moderate Oct 3, 2018
ESSENTIO Pacemaker
FDA Devices Moderate Oct 3, 2018
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
FDA Devices Moderate Oct 3, 2018
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy 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 interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combinati
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 material in tissues at the operative site.
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 assist in the placement of suture material in tissues at the operative site.
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 May 16, 2018
Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA Devices Moderate May 16, 2018
Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA Devices Moderate May 16, 2018
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA Devices Moderate May 16, 2018
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
FDA Devices Moderate May 16, 2018
Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
FDA Devices Moderate May 16, 2018
Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
FDA Devices Moderate Mar 28, 2018
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
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 establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urotheli
FDA Devices Moderate Mar 28, 2018
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
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 for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter with its extended tip is also designed for internal drainage from the ureteropelvic junction to the bladder.
FDA Devices Moderate Mar 28, 2018
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urotheli
FDA Devices Moderate Mar 28, 2018
Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
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-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939293052030 (Material Description Innova
FDA Devices Moderate Feb 28, 2018
Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939180051870 (Material Description Innova-E
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
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 Jan 24, 2018
VALITUDE X4 CRT-P Pacemaker
FDA Devices Moderate Jan 24, 2018
ESSENTIO EL DR Pacemaker
FDA Devices Moderate Jan 24, 2018
VISIONIST X4 CRT-P Pacemaker
FDA Devices Moderate Jan 24, 2018
PROPONENT VDD SL Pacemaker
FDA Devices Moderate Jan 24, 2018
ALTRUA 2 DR Pacemaker
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).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
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