Boston Scientific recalls
Boston Scientific appears in 655 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including…
FDA Device · Class II · 2019-05-29 · Boston Scientific - AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber opt…
FDA Device · Class II · 2019-05-29 · Boston Scientific - AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including…
FDA Device · Class II · 2019-05-29 · Boston Scientific - AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber op…
FDA Device · Class II · 2019-05-29 · Boston Scientific - AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System incl…
FDA Device · Class II · 2019-05-29 · Boston Scientific - AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a…
FDA Device · Class II · 2019-05-29 · Boston Scientific - AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a…
FDA Device · Class II · 2019-05-29 · Boston Scientific - Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
FDA Device · Class II · 2019-03-20 · Boston Scientific - Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
FDA Device · Class II · 2019-03-20 · Boston Scientific - Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices duri…
FDA Device · Class II · 2019-02-27 · Boston Scientific - IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequen…
FDA Device · Class III · 2019-01-16 · Boston Scientific - IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequen…
FDA Device · Class III · 2019-01-16 · Boston Scientific - Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency…
FDA Device · Class III · 2019-01-16 · Boston Scientific - The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intende…
FDA Device · Class II · 2018-11-28 · Boston Scientific - Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0,…
FDA Device · Class II · 2018-10-31 · Boston Scientific - PROPONENT Pacemaker
FDA Device · Class II · 2018-10-03 · Boston Scientific - VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
FDA Device · Class II · 2018-10-03 · Boston Scientific - ESSENTIO Pacemaker
FDA Device · Class II · 2018-10-03 · Boston Scientific - Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospita…
FDA Device · Class II · 2018-10-03 · Boston Scientific - ACCOLADE Pacemaker
FDA Device · Class II · 2018-10-03 · Boston Scientific - VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
FDA Device · Class II · 2018-10-03 · Boston Scientific - Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through w…
FDA Device · Class II · 2018-08-15 · Boston Scientific - PFR Kit- Pinnacle, Anterior Apical
FDA Device · Class II · 2018-05-16 · Boston Scientific - Capio RP
FDA Device · Class II · 2018-05-16 · Boston Scientific - Posterior LITE w/ Capio SLIM
FDA Device · Class II · 2018-05-16 · Boston Scientific - Capio CL
FDA Device · Class II · 2018-05-16 · Boston Scientific - Capio Open Access Box 4 (Capio OPC)
FDA Device · Class II · 2018-05-16 · Boston Scientific - Uphold Vaginal Support System
FDA Device · Class II · 2018-05-16 · Boston Scientific - Uphold LITE w/ Capio SLIM
FDA Device · Class II · 2018-05-16 · Boston Scientific - Capio Standard Box 4 (Capio PC)
FDA Device · Class II · 2018-05-16 · Boston Scientific - PFR Kit- Pinnacle, Posterior
FDA Device · Class II · 2018-05-16 · Boston Scientific - Capio SLIM Box 5, Model #M0068318261
FDA Device · Class II · 2018-05-16 · Boston Scientific - Capio SLIM Suture Capturing Device, Model #M0068318250
FDA Device · Class II · 2018-05-16 · Boston Scientific - SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA Device · Class II · 2018-03-28 · Boston Scientific - Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish pe…
FDA Device · Class II · 2018-03-28 · Boston Scientific - Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are de…
FDA Device · Class II · 2018-03-28 · Boston Scientific - Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to est…
FDA Device · Class II · 2018-03-28 · Boston Scientific - Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to est…
FDA Device · Class II · 2018-03-28 · Boston Scientific - Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is inten…
FDA Device · Class II · 2018-03-28 · Boston Scientific - Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is inten…
FDA Device · Class II · 2018-03-28 · Boston Scientific - Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures
FDA Device · Class II · 2018-03-14 · Boston Scientific - Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures
FDA Device · Class II · 2018-03-14 · Boston Scientific - Innova Self-Expanding Stent System, 180mm
FDA Device · Class II · 2018-02-28 · Boston Scientific - Innova Self-Expanding Stent System, 200 mm
FDA Device · Class II · 2018-02-28 · Boston Scientific - ACCOLADE MRI SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ALTRUA 2 DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ACCOLADE EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ACCOLADE MRI DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ALTRUA 2 SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO MRI EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific