Boston Scientific Corporation
414 recalls on record · Latest: Feb 11, 2026
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 May 16, 2018
Uphold Vaginal Support System; Model #M0068317080. 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