Reported Jan 21, 2026 · Ongoing
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 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 |
| 3 | Catheter, Angioplasty, Peripheral, Transluminal |
- Lot codes and dates
1) GTIN 08714729796527Batch Number 37370117exp. 3-Sept-282) GTIN 08714729796756Batch Number 37416646exp. 9-Sept-28
- Amount recalled
- 21 units
Where it was sold
Why it was recalled
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
This product could cause temporary or reversible health problems — stop using it.
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