FDA Medical Device Recalls (openFDA)
Medtronic, Inc.: Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
- Recall number
- Z-0063-2008
- Recalling firm
- Medtronic, Inc.
- Product
- Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
- Status
- Terminated
- Initiated
- 2007-08-29
- Posted
- 2007-10-31
- Terminated
- 2008-09-08
- Reason
- Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.
- Root cause
- Labeling design
- 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.
- Quantity
- 13,940 units
- Distribution
- Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK.
- Lot, serial or model codes
- Al lot numbers
- 510(k) numbers
- ["K061958"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28