Z-0523-04

Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029

Name: Z-0523-04 Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
Creator: Medtronic, Inc.
Published: 2004-01-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-01-14 / Terminated

FDA source

Medtronic, Inc. began a recall of Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029 on 2004-01-14. The reason FDA records is "Catheter distal tip may separate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0523-04
Status: Terminated
Initiated: 2004-01-14
Posted: 2004-02-10
Terminated: 2004-11-15
Recalling firm: Medtronic, Inc.
Product: Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Catheter distal tip may separate
FDA root cause: Other
Action: Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital.
Quantity in commerce: 20 units
Distribution: NC, WA
Product codes and lots: Lot Number: 160760 Expiration Date: 2006-12

Product code DQO

K932092Class IIUsci Angiographic CatheterC.R. Bard, Inc. / cleared 1993-07-29

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)