Z-0392-06

Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models...

Name: Z-0392-06 Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models...
Creator: Medtronic Gastroenterology / Urology
Published: 2005-12-09
License: https://open.fda.gov/license/

Medtronic Gastroenterology / Urology / initiated 2005-12-09 / Terminated / root cause: manufacturing process

FDA source

Medtronic Gastroenterology / Urology began a recall of Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and... on 2005-12-09. The reason FDA records is "Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0392-06
Status: Terminated
Initiated: 2005-12-09
Posted: 2006-01-13
Terminated: 2006-12-21
Recalling firm: Medtronic Gastroenterology / Urology
Product: Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA
Product code: FFT Electrode, Ph, Stomach
Reason for recall: Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the Digitrapper pH recorder.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Letters will be sent to distributors, end-users and Medtronic Field Personnel. The end-user will be asked to return via fax a confirmation/customer receipt. Letters identify the affected catalog number and lot numbers. Customers are asked to return affected product and will receive replacement product.
Quantity in commerce: 140 catheters
Distribution: CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal
Product codes and lots: Lot numbers 571, 606, 695, 754, 952, 945, 1024, 1066

Product code FFT

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)