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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.
May 26, 2021Medical DevicesFDA
Boston Scientific Corporation recalls ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of
Hazard: One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
May 26, 2021Medical DevicesFDA
Boston Scientific Corporation recalls VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for
Hazard: The firm has received reports of stent migration after implantation
May 26, 2021Medical DevicesFDA
Boston Scientific Corporation recalls VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous va
Hazard: The firm has received reports of stent migration after implantation
May 5, 2021Medical DevicesFDA
Boston Scientific Corporation recalls EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatmen
Hazard: May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
May 5, 2021Medical DevicesFDA
Boston Scientific Corporation recalls UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material
Hazard: Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
May 5, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in th
Hazard: Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
April 28, 2021Medical DevicesFDA
Boston Scientific Corporation recalls The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of s
Hazard: An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
April 21, 2021Medical DevicesFDA
Boston Scientific Corporation recalls MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and pl
Hazard: The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
April 21, 2021Medical DevicesFDA
Boston Scientific Corporation recalls MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then label
Hazard: The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
March 10, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311
Hazard: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
March 10, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00
Hazard: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
March 10, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN:
Hazard: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
February 17, 2021Medical DevicesFDA
Boston Scientific Corporation recalls EMBLEM MRI S-ICD Model A219
Hazard: Electrical overstress may lead to device malfunction.
February 17, 2021Medical DevicesFDA
Boston Scientific Corporation recalls EMBLEM S-ICD Model A209
Hazard: Electrical overstress may lead to device malfunction.
February 3, 2021Medical DevicesFDA
Boston Scientific Corporation recalls EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Hazard: Accelerated battery depletion may result in a need for device replacement earlier than expected.
February 3, 2021Medical DevicesFDA
Boston Scientific Corporation recalls EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Hazard: Accelerated battery depletion may result in a need for device replacement earlier than expected.
January 27, 2021Medical DevicesFDA
Boston Scientific Corporation recalls EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Hazard: There is potential for fractures which results in the inability to delivery therapy.
January 27, 2021Medical DevicesFDA
Boston Scientific Corporation recalls ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scie
Hazard: Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
January 20, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS
Hazard: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
January 20, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS
Hazard: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
January 20, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS
Hazard: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
January 20, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS
Hazard: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
January 20, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS
Hazard: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
January 20, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS
Hazard: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
January 13, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent
Hazard: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
January 13, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent
Hazard: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
January 13, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent
Hazard: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
January 13, 2021Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intend
Hazard: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
January 13, 2021Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intend
Hazard: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
January 13, 2021Medical DevicesFDA
Boston Scientific Corporation recalls AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intend
Hazard: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity