—#36253

Product

VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K021593
Affected lot / code info: Product Code 67021055, lot X0704002

Why it was recalled

Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process.

Root cause (FDA determination)

Other

Action the firm took

Packets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Distributed to 57 accounts throughout the United States and three international accounts.

Timeline

Recall initiated: 2004-12-07
Posted by FDA: 2005-01-26
Terminated: 2008-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36253. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.