United StatesThe recall affects Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheters (4F) sizes 2.5 mm x 120 mm, 150 cm (REF H74939186251210, GTIN 08714729796527, Batch 37370117, exp. 3‑Sept‑28) and 3.5 mm x 120 mm, 150 cm (REF H74939186351210, GTIN 08714729796756, Batch 37416646, exp. 9‑Sept‑28), manufactured 12‑Sep‑2025 through 13‑Oct‑2025. They were removed because a manufacturing process variation may cause inflation/deflation difficulty during use in the peripheral vasculature; the processing variation has been addressed.
What's being recalled
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
Recalling firm: Boston Scientific Corporation, Maple Grove, MN, United States.
How to identify it
1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28; 2) GTIN 08714729796756, Batch Number 37416646, exp. 9-Sept-28
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada