FDA Medical devices recall ·
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F… recall
- Recall number
- Z-1042-2026
- Date
- (initiated December 3, 2025)
- Company / brand
- Boston Scientific Corporation
1 Scimed Pl, Maple Grove, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 21 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28; 2) GTIN 08714729796756, Batch Number 37416646, exp. 9-Sept-28
Distribution
US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.
States: California Florida Illinois Massachusetts Minnesota New York Ohio Texas Virginia West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1042-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.