Z-1159-06

Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by...

Name: Z-1159-06 Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by...
Creator: Medtronic Gastroenterology / Urology
Published: 2006-04-06
License: https://open.fda.gov/license/

Medtronic Gastroenterology / Urology / initiated 2006-04-06 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Gastroenterology / Urology began a recall of Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE... on 2006-04-06. The reason FDA records is "Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is sequentially 1 through 8, from the...". 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-1159-06
Status: Terminated
Initiated: 2006-04-06
Posted: 2006-06-22
Terminated: 2007-01-16
Recalling firm: Medtronic Gastroenterology / Urology
Product: Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.
Product code: KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Reason for recall: Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is sequentially 1 through 8, from the distal to the proximal end of the catheter.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recall initiated to International accounts on 04/05/06 and within US on 04/06/06 via an Urgent Recall Notification. The letter informs them of the manufacturing defect, requests return for credit of any unused inventory and requests accounting of all previously used catheters. Distributors are instructed to sent a letter to their customers to request product return.
Quantity in commerce: 94 catheters (US - 4; OUS - 90)
Distribution: Worldwide Distribution-including states of IL, NC, NY. and countries of Austria, Chile, Finland, Germany, Greece, Hong Kong, Italy, Japan, Lebanon, Norway, Peru, Portugal, Saudi Arabi, Spain
Product codes and lots: Lots 0001391 and 0001464

Product code KLA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)