Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
This recall has been terminated (originally issued October 31, 2007).
- Company
- Medtronic, Inc.
- Recall Initiated
- August 29, 2007
- Posted
- October 31, 2007
- Terminated
- September 8, 2008
- Recall Number
- Z-0063-2008
- Quantity
- 13,940 units
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK.
Lot / Code Info
Al lot numbers
Root Cause
Labeling design
Action Taken
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.
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