—#217716

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

FDA product code: LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K111295
Affected lot / code info: 1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28; 2) GTIN 08714729796756, Batch Number 37416646, exp. 9-Sept-28

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.

Root cause (FDA determination)

Process change control

Action the firm took

Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 12/3/2025 by letter delivered via a courier service. The notice explained the issue, clinical impact to the patient, and requested the following actions: "Instructions: 1. Further distribution or use of any remaining devices (Attachment 1) affected by this removal should cease immediately. Do NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. If you are a distributor, this notice must be forwarded to your customers to ensure notification of this device removal is carried out to the end-user level. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page four. 5. Return affected devices." For questions regarding this communication, please contact your local Boston Scientific representative.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

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

Timeline

Recall initiated: 2025-12-03
Posted by FDA: 2026-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217716. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.