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Boston Scientific Corp

Boston Scientific Corp Recalls

All product recalls associated with Boston Scientific Corp.

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Recall Summary

Total Recalls

506

Past Year

Class I (Serious)

Most Recent

Sep 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 341–360 of 506 recalls

Boston Scientific Corp: Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, ...

These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.

FDAOct 17, 2008Nationwide• Boston Scientific Corp

Boston Scientific Corporation: Atlantis PV Peripheral Imaging Catheter, model number H74...

Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.

FDAOct 9, 2008PR• Boston Scientific Corporation

Boston Scientific Corporation: Excelsior SL-10 Microcatheter, placed in sterile pouch. ...

Packaging issue may result in failure to maintain sterile barrier.

FDAOct 7, 2008Nationwide• Boston Scientific Corporation

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Boston Scientific Corporation: Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 c...

Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device.

FDAOct 7, 2008Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific iLab Ultrasound Imaging System, models ...

Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected.

FDASep 5, 2008Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018...

Boston Scientific is initiating a voluntary recall of the Platinum Plus" Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to

FDAAug 25, 2008CA, FL, GA +16 more• Boston Scientific Corporation

Boston Scientific Corporation: Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018...

Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to

FDAAug 25, 2008CA, FL, GA +16 more• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific Platinum Plus Guidewire. Material No. ...

Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary Guidewires could be damaged in certain locations. This damage of the coating creates the potential for small particles of the PTFE coating to detach from the wi

FDAJun 19, 2008AL, AZ, AR +41 more• Boston Scientific Corporation

Boston Scientific Corporation One Boston: EndoVive Safety PEG Kits 24 F Universal Product Number (...

Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG

FDAJun 17, 2008NJ, SC, TN +2 more• Boston Scientific Corporation One Boston

Boston Scientific Corporation One Boston: EndoVive Safety PEG Kits 20 F Universal Product Number (...

Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG

FDAJun 17, 2008NJ, SC, TN +2 more• Boston Scientific Corporation One Boston

Boston Scientific Corporation: Boston Scientific NexStent Monorail, NexStent Carotid Ste...

Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Since the potential for the tip to detach occurs during delivery of the sten

FDAJun 6, 2008Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific FilterWire EZ" Embolic Protection Syste...

Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be missing. If the product does not include a DFU and the user is unable to find a copy, the user will have to seek another product box containing the DFU. This may

FDAMay 20, 2008AL, AK, AZ +48 more• Boston Scientific Corporation

Boston Scientific Corporation: iReview" Software (Accessory To) iLab Ultrasound Imaging ...

The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.

FDAMay 2, 2008AZ, CA, FL +3 more• Boston Scientific Corporation

Boston Scientific Corp: Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 ...

The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.

FDAApr 30, 2008Nationwide• Boston Scientific Corp

Boston Scientific Corp: Boston Scientific Flexima Biliary Stent System, 200 cm lo...

Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package.

FDAApr 2, 2008Nationwide• Boston Scientific Corp

Boston Scientific Corp: Boston Scientific SteeroCath-T Ablation Catheter. This c...

Package sterile barrier may be breached, compromising sterility.

FDAFeb 14, 2008Nationwide• Boston Scientific Corp

Boston Scientific Corp: Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manu...

Package sterile barrier may be breached, compromising sterility.

FDAFeb 14, 2008Nationwide• Boston Scientific Corp

Boston Scientific Corporation One Boston: Boston Scientific Mach 1 peripheral Guide Catheter 6F, H...

Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

FDAFeb 7, 2008AL, AZ, AR +21 more• Boston Scientific Corporation One Boston

Boston Scientific Corporation One Boston: Boston Scientific Mach 1 Guide Catheter 6F, IM Internal M...

Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

FDAFeb 7, 2008AL, AZ, AR +21 more• Boston Scientific Corporation One Boston

Boston Scientific CRM Corp: VITALITY DR+ Implantable Cardioverter Defibrillator (ICD)...

Laceration Risk

Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This update identifies additional VITALITY ICD

FDAJan 7, 2008Nationwide• Boston Scientific CRM Corp