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;

Recall Summary Boston Scientific is recalling certain batches of Coyote Over-the-Wire PTA Balloon Dilation Catheters (two specific sizes) manufactured between September 12, 2025 and October 13, 2025. These devices may have difficulty inflating or deflating during use due to a manufacturing process variation. The affected catheters are used in procedures to open narrowed blood vessels in peripheral areas of the body.

Recalling firm

Boston Scientific Corporation

Product

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

Reason

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...

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2025-12-03

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ea40a041-35eb-4a25-b58c-62612fc6a94c