Z-0924-04

Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

Name: Z-0924-04 Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081
Creator: Medtronic Gastroenterology / Urology
Published: 2004-04-28
License: https://open.fda.gov/license/

Medtronic Gastroenterology / Urology / initiated 2004-04-28 / Terminated

FDA source

Medtronic Gastroenterology / Urology began a recall of Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081 on 2004-04-28. The reason FDA records is "Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0924-04
Status: Terminated
Initiated: 2004-04-28
Posted: 2004-07-20
Terminated: 2005-11-21
Recalling firm: Medtronic Gastroenterology / Urology
Product: Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081
Product code: FFX System, Gastrointestinal Motility (Electrical)
Reason for recall: Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.
FDA root cause: Other
Action: Letters dated April 28, 2004 were sent to the consignees. Enclosed with the letter to each consignee were replacement power cord(s). The letters instruct consignees to replace the current power cord by following instructions enclosed with the letter.
Quantity in commerce: 42 units
Distribution: The devices were distributed nationwide in the United States.
Product codes and lots: All serial numbers

Product code FFX

K981733Class IIDigitrapper Delta, Model 9043G0201 and Polygram '98 Ph Extension Model 9043S0111Medtronic Functional Diagnostics A/S / cleared 1999-02-04

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)