Boston Scientific Corporation recalls Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter

Recalling company

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 this removal.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Dec 3, 2025

Reported

Jan 21, 2026

Distribution

US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.

Status

Ongoing

Quantity

21 units

Lot / codes

1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28; 2) GTIN 08714729796756, Batch Number 37416646, exp. 9-Sept-28

Company location

Maple Grove, MN

Recall type

Voluntary: Firm initiated

Recall number

Z-1042-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1042-2026 in the FDA Enforcement Report. Also see FDA recall press releases.