Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Boston Scientific : Recalls more than 1M angiographic catheters

Boston Scientific has globally recalled over 1 million angiographic catheters due to increased complaints about difficulties advancing the guidewire through the device’s channel. The FDA cited evidence of the catheter’s polyurethane layer detaching, with material separating from the inner lining in some cases. Initiated on March 21, the recall addresses these concerns.

Patients treated with the device face no risks, according to Boston Scientific, which provided instructions for returning unused, potentially affected devices to physicians.

Affected products include Expo 5Fr Angiographic Catheters for diagnosing percutaneous coronary intervention procedures, classified by the FDA as Class I, signifying a severe risk.

Boston Scientific advised hospitals to halt use and isolate recalled products. While no patient harm reports emerged, the company acknowledged potential severe consequences, like stroke or myocardial infarction, though rare. All reported issues occurred externally.