FDA recall, , Moderate risk
Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheters
The Coyote balloon catheter may not inflate or deflate properly during use.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation is removing certain batches of its Coyote Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices because of the potential for inflation/deflation difficulty during use in the peripheral vasculature. The company's internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate or deflate.
The recall affects 21 units distributed nationwide in the states of California, Florida, Illinois, Massachusetts, Minnesota, New York, Ohio, Texas, Virginia and West Virginia. The company began the removal on December 3, 2025, and the FDA added it to its Enforcement Report on January 9, 2026. The affected products include the 2.5mm x120mm, 150 cm catheter, model REF H74939186251210, and the 3.5mm x120mm, 150 cm catheter, model REF H74939186351210.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheter
- Model number
- REF H74939186251210
- REF H74939186351210
- UDI-DI
- 08714729796527
- 37370117
- 08714729796756
- 37416646
From the FDA notice
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Massachusetts, West Virginia, Ohio, California, Minnesota, New York, Virginia, Illinois Texas, Florida, Illinois.
- Company
- Boston Scientific CorporationMaple Grove, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98149
- Recall number
- Z-1042-2026
- Quantity recalled
- 21 units
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
