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.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoab
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cry
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablati
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
May 27, 2020Medical DevicesFDA
Boston Scientific Corporation recalls AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatmen
Hazard: A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
May 6, 2020Medical DevicesFDA
Boston Scientific Corporation recalls iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Hazard: Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior.
May 6, 2020Medical DevicesFDA
Boston Scientific Corporation recalls MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, v
Hazard: To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single un
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 29, 2020Medical DevicesFDA
Boston Scientific recalls Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
Hazard: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
April 1, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Imager II 5F Angiographic Catheters, 5 units per package.
Hazard: Potential for tip detachment of Imager II 5F Angiographic Catheters
March 25, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable ca
Hazard: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
March 25, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming Sy
Hazard: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
December 25, 2019Medical DevicesFDA
Boston Scientific Corporation recalls AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105
Hazard: Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
December 18, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for
Hazard: During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
December 18, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for
Hazard: During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Mono
Hazard: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. R
Hazard: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catal
Hazard: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Cat
Hazard: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
December 4, 2019Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
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 15cm UPN: M005337206
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