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Boston Scientific Recalls

651 recalls on record · June 27, 2012 to August 12, 2026 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

October 31, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M00
Hazard: Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
October 3, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is inte
Hazard: There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
October 3, 2018Medical DevicesFDA
Boston Scientific Corporation recalls VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Hazard: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
October 3, 2018Medical DevicesFDA
Boston Scientific Corporation recalls VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Hazard: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
October 3, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE Pacemaker
Hazard: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
October 3, 2018Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT Pacemaker
Hazard: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
October 3, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ESSENTIO Pacemaker
Hazard: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
August 15, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a
Hazard: Potential polymer material degradation.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prol
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prola
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ
Hazard: FDA Class II
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prola
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during ope
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assis
Hazard: Potential for Capio sutures to break and /or detach.
May 16, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open
Hazard: Potential for Capio sutures to break and /or detach.
March 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Hazard: Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
March 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is i
Hazard: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
March 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostom
Hazard: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
March 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostom
Hazard: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
March 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter
Hazard: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
March 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter
Hazard: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
March 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting M
Hazard: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
March 14, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Hazard: Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
March 14, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Hazard: Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
February 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage:
Hazard: Stent possibly unable to be fully released from the delivery system.
February 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage:
Hazard: Stent possibly unable to be fully released from the delivery system.