Z-0800-03

Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH

Name: Z-0800-03 Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH
Creator: Medtronic, Inc.
Published: 2003-03-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-03-17 / Terminated / root cause: labeling and UDI

FDA source

Medtronic, Inc. began a recall of Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH on 2003-03-17. The reason FDA records is "The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label". 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-0800-03
Status: Terminated
Initiated: 2003-03-17
Posted: 2003-05-09
Terminated: 2008-02-19
Recalling firm: Medtronic, Inc.
Product: Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH
Reason for recall: The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Medtronic AVE notified the firm''s sales representatives on 3/17/03 by e-mail to retrieve affected product from the hospital and return it Danvers, MA. Each sales rep. is required to document the notification and accounting for the devices returned from the field.
Distribution: AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary
Product codes and lots: Lot Number: 122596

K981198Class IIMedtronic Zuma Guiding CatheterMedtronics Interventional Vascular / cleared 1998-08-07

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)