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Boston Scientific Corporation

Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

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Recall Summary

Total Recalls

412

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 301–320 of 412 recalls

Boston Scientific Corporation: Boston Scientific Impulse Flextrusion Shaft, Angiographic...

Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scientific has determined that the sterile barrier in the packaging may be compromised. During internal inspections, they discovered gaps between the side seals and the top seal approximately 3/8 in len

FDAAug 5, 2009DC, PR• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific Expo, Angiographic Catheter, Sterilized...

FDAAug 5, 2009DC, PR• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific Wiseguide, Guide Catheter, Sterilized w...

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FDAAug 5, 2009DC, PR• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific HydroThermAblator Endometrial Ablation ...

Fire/Burn Risk

Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.

FDAJul 31, 2009Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Prolieve Thermodilatation Catheter Kit, a Transurethral M...

Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.

FDAJul 20, 2009Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific (1) Flexima Regular Biliary Catheter ...

Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the

FDAJul 1, 2009Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific Clipping Device, Resolution Clip, work...

The clip may not deploy or, if deployed, the clip may not release from the tissue.

FDAJun 17, 2009Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific Fort Guide Wire, Floppy Marker Wire, 30...

Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the

FDAMay 12, 2009AR, CA, FL +2 more• Boston Scientific Corporation

Boston Scientific Corporation: Neuroform 3 Microdelivery Stent System, Model Number M003...

Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton.

FDAMay 8, 2009Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific, Flexima and Percuflex Drainage Cathete...

Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

FDAMar 18, 2009DC, PR• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific Wiseguide Guide Catheter, Sterilized. ...

Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. There have been 41 complaints in the US as

FDAMar 11, 2009PR• Boston Scientific Corporation

Boston Scientific Corporation: Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3....

Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.

FDADec 24, 2008Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3...

FDADec 24, 2008Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Flextome Cutting Balloon Device Over-the-Wire Delivery Sy...

Laceration Risk

For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter Flextome Cutting Balloon device is for a 3.5mm diameter Flextome Cutting Balloon device. This labeling discrepancy could create a procedural delay as users seek to explain the discr

FDANov 21, 2008Nationwide• Boston Scientific Corporation

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

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 46-601, 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: 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