Z-0597-05

Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are...

Name: Z-0597-05 Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are...
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2005-02-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-02-09 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices... on 2005-02-09. The reason FDA records is "Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs...". 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-0597-05
Status: Terminated
Initiated: 2005-02-09
Posted: 2005-03-11
Terminated: 2006-12-28
Recalling firm: Medtronic, Inc.
Product: Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Medtronic Sales Representatives contacted affected physicians starting 02/10/05 to deliver an Important Patient Management Information. The letter recommended patient managment options including quarterly follow-ups, programming Patient Alert to 'On-High', provide magnet to patients to check device status and inform patients that should they expereicnce warmth in the area surrounding the ICD to seek prompt care.
Quantity in commerce: 21,926 total, (13,508 in US & 8,418 OUS)
Distribution: worldwide
Product codes and lots: Model 7230 Marquis VR (serial numbers listed include all affected devices but may include some unaffected devices. Patients are recommended to check with their doctor for exact serial numbers affected.) 7230B S-Series: PLW600001S - PLW600646S. 7230Cx H-Series: PKD100001H - PKD116584H, PKD117397H, PKD117553H, PKD117735H, and PKD117741H. R-Series: PKD200084R - PKD200536R, PKD600016R - PKD600113R. S-Series: PKD600009S - PKD608391S. 7230E S-Series: PLY600001S - PLY600749S and PLY600839S.

Product code LWS

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)