—#124145

Product

TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.

FDA product code: FGX — Snare, Non-Electrical
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Lot Numbers: H13061102, H13061104, H13062401, H13062402, H13071302, H13082603

Why it was recalled

Sterility of device may be compromised due to lack of pouch seal integrity

Root cause (FDA determination)

Packaging process control

Action the firm took

Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.

Timeline

Recall initiated: 2013-11-20
Posted by FDA: 2014-01-11
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.