Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
FDA Recall Z-0063-2008 · Posted 2007-10-31
Recalling FirmMedtronic, Inc.
Recall StatusTerminated
Product CodeDQA
Date Initiated2007-08-29
Date Terminated2008-09-08
Product Quantity13,940 units
Reason for Recall
Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.
Firm Action
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.
Root Cause
Labeling design
Distribution Pattern
Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.