—#64325

Product

Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)

FDA product code: DQA — Oximeter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K061958
Affected lot / code info: Al lot numbers

Why it was recalled

Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.

Root cause (FDA determination)

Labeling design

Action the firm took

Medtronic has notifed sales representatives to visit Cath lab site with the letter dated August 29, 2007 and educate the user, provide the Safety Alert Letter and document delivery of the letter with the confirmation form.

Recalling firm

Firm: Medtronic, Inc.
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern: Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK.

Timeline

Recall initiated: 2007-08-29
Posted by FDA: 2007-10-31
Terminated: 2008-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64325. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.