Z-0830-06

Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements...

Name: Z-0830-06 Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements...
Creator: Medtronic Gastroenterology / Urology
Published: 2006-01-25
License: https://open.fda.gov/license/

Medtronic Gastroenterology / Urology / initiated 2006-01-25 / Terminated / root cause: manufacturing process

FDA source

Medtronic Gastroenterology / Urology began a recall of Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic... on 2006-01-25. The reason FDA records is "Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patient safety is not compromised. Clinicians however should review...". 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-0830-06
Status: Terminated
Initiated: 2006-01-25
Posted: 2006-05-03
Terminated: 2006-12-21
Recalling firm: Medtronic Gastroenterology / Urology
Product: Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.
Product code: FFT Electrode, Ph, Stomach
Reason for recall: Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patient safety is not compromised. Clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.
Root cause tag: manufacturing process
FDA root cause: Other
Action: An Urgent Recall letter was issued to all affected customers 1/25/2006. This letter described the issue and listed what actions customers were to take to return affected product.
Quantity in commerce: 25 individual catheters
Distribution: within US only: MI, PA, TX
Product codes and lots: Lot 0001491

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)