Brand

Boston Scientific Corporation Recalls

383 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Boston Scientific Corporation.

383Total Recalls
91Critical
8.6MUnits Affected
Mar 30, 2026Most Recent
All Recalls

Every Boston Scientific Corporation Recall

Sorted by most recent. Click any recall for full details.

383 recalls
High RiskFDA
Boston Scientific Corporation
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System ...
Surgical Devices·3 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser Syste...
Surgical Devices·2 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System ...
Surgical Devices·1 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a...
Surgical Devices·8 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including ...
Surgical Devices·18 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System in...
Surgical Devices·27 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Medical Implants·18 affected·Dec 26, 2018
RecallFDA
Boston Scientific Corporation
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiof...
Cardiac Devices·1,282 affected·Nov 28, 2018
RecallFDA
Boston Scientific Corporation
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofr...
Cardiac Devices·1,282 affected·Nov 28, 2018
RecallFDA
Boston Scientific Corporation
IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiof...
Cardiac Devices·1,282 affected·Nov 28, 2018
High RiskFDA
Boston Scientific Corporation
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
PROPONENT Pacemaker
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
ACCOLADE Pacemaker
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R...
Cardiac Devices·793 affected·Jun 20, 2018
High RiskFDA
Boston Scientific Corporation
Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placemen...
Medical Devices·60,538 affected·Feb 12, 2018
High RiskFDA
Boston Scientific Corporation
Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic ...
Medical Devices·21,051 affected·Feb 12, 2018
High RiskFDA
Boston Scientific Corporation
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Medical Devices·34 affected·Feb 12, 2018
High RiskFDA
Boston Scientific Corporation
Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
Medical Devices·1,258 affected·Feb 12, 2018
High RiskFDA
Boston Scientific Corporation
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Surgical Devices·5,026 affected·Dec 20, 2017
High RiskFDA
Boston Scientific Corporation
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establ...
Surgical Devices·3,762 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is...
Surgical Devices·2,614 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended ...
Surgical Devices·1,480 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit th...
Surgical Devices·31,005 affected·Dec 11, 2017
High RiskFDA
Boston Scientific Corporation
PROPONENT SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
VISIONIST CRT-P Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ESSENTIO DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ALTRUA 2 EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
PROPONENT DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
VALITUDE CRT-P Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
PROPONENT EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ESSENTIO SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ALTRUA 2 SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascu...
Medical Implants·22,916 affected·Nov 6, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE X4 CRT-D, Model G447, Sterile.
Medical Devices·11 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE EL ICD VR, Model D432, Sterile.
Medical Devices·5 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
MOMENTUM X4 CRT-D, Model G138, Sterile.
Medical Devices·4 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE EL ICD DR, Model D433, Sterile.
Medical Devices·12 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with he...
Cardiac Devices·4 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Surgical Devices·9 affected·Sep 22, 2017
High RiskFDA
Boston Scientific Corporation
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Surgical Devices·2 affected·Sep 22, 2017
High RiskFDA
Boston Scientific Corporation
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of l...
Cardiac Devices·12,450 affected·Jun 29, 2017
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended ...
Medical Implants·9,200 affected·Jun 29, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Surgical Devices·32 affected·Jun 1, 2017