Z-0618-03

Atakr II RF Power Generator, Models 4802 and 4803

Name: Z-0618-03 Atakr II RF Power Generator, Models 4802 and 4803
Creator: Medtronic,Inc/Rice Creek Facil
Published: 2002-11-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2002-11-25 / Terminated

FDA source

Medtronic,Inc/Rice Creek Facil began a recall of Atakr II RF Power Generator, Models 4802 and 4803 on 2002-11-25. The reason FDA records is "An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0618-03
Status: Terminated
Initiated: 2002-11-25
Posted: 2003-03-06
Terminated: 2003-11-04
Recalling firm: Medtronic, Inc.
Product: Atakr II RF Power Generator, Models 4802 and 4803
Product code: DQY Catheter, Percutaneous
Reason for recall: An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.
FDA root cause: Other
Action: An "Important Product Management Information" letter dated November 25, 2002 was sent to the affected consignees (hospitals) and it recommended certain actions to avoid the problem and stated that a software revision, (version 1.36) had been developed to eliminate the problem.
Quantity in commerce: 775 units
Product codes and lots: All units

Product code DQY

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)