Z-0063-2008

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

Name: Z-0063-2008 Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
Creator: Medtronic, Inc.
Published: 2007-08-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-08-29 / Terminated / root cause: labeling and UDI

FDA source

Medtronic, Inc. began a recall of Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US) on 2007-08-29. The reason FDA records is "Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0063-2008
Status: Terminated
Initiated: 2007-08-29
Posted: 2007-10-31
Terminated: 2008-09-08
Recalling firm: Medtronic, Inc.
Product: Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
Product code: DQA Oximeter
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 13,940 units
Distribution: Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK.
Product codes and lots: Al lot numbers

Product code DQA

K061958Class IIMedtronic Export Xt CatheterMedtronic Vascular / cleared 2006-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)