Home / Brands / Boston Scientific
Boston Scientific Recalls
651 recalls on record · June 27, 2012 to August 12, 2026 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
Hazard: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
September 25, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Hazard: Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
September 25, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Hazard: Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
September 11, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Hazard: Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Aurig
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser S
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the A
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the A
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 3
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
May 29, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga
Hazard: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
March 20, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Hazard: The sterile barrier may contain packaging seal defects.
March 20, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Hazard: The sterile barrier may contain packaging seal defects.
February 27, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intrav
Hazard: A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
January 16, 2019Medical DevicesFDA
Boston Scientific Corporation recalls IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a
Hazard: Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
January 16, 2019Medical DevicesFDA
Boston Scientific Corporation recalls IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a
Hazard: Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
January 16, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a c
Hazard: Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
November 28, 2018Medical DevicesFDA
Boston Scientific Corporation recalls The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The
Hazard: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.