Z-0208-2007

Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed...

Name: Z-0208-2007 Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed...
Creator: Medtronic Vascular
Published: 2006-11-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-11-01 / Terminated / root cause: packaging

FDA source

Medtronic Vascular began a recall of Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403 on 2006-11-01. The reason FDA records is "Sterility may be compromised as evidenced by a loss of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0208-2007
Status: Terminated
Initiated: 2006-11-01
Posted: 2006-11-22
Terminated: 2007-12-05
Recalling firm: Medtronic, Inc.
Product: Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Sterility may be compromised as evidenced by a loss of package integrity.
Root cause tag: packaging
FDA root cause: Other
Action: On 11/1/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Quantity in commerce: 502
Distribution: Worldwide, including USA, Switzerland, France, Belgium, Germany.
Product codes and lots: All Codes.

Product code ITX

K031920Class IICrosspoint Transaccess Catheter, Model Ta-Xp-001Trans Vascular Incorporated / cleared 2003-07-23

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)