Boston Scientific is recalling 21 units of the Coyote Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter. The recall involves specific batches of the 2.5mm x 120mm and 3.5mm x 120mm models manufactured between September 12, 2025, and October 13, 2025. These catheters were found to have a manufacturing defect that can make them difficult to inflate or deflate properly during medical procedures.
A manufacturing process variation caused some catheters to fail during inflation or deflation in the peripheral blood vessels. This failure could cause delays during a procedure or lead to potential injury of the patient's vascular system.
Firm initiated removal via letter.
Catheter, Angioplasty, Peripheral, Transluminal; Recall #: Z-1042-2026
Catheter, Angioplasty, Peripheral, Transluminal; Recall #: Z-1042-2026
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.