FDA Medical Device Recalls (openFDA)
Medtronic Inc. Cardiac Rhythm Managment: Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy 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.
- Recall number
- Z-0600-05
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- Product
- Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy 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.
- Status
- Terminated
- Initiated
- 2005-02-09
- Posted
- 2005-03-11
- Terminated
- 2006-12-28
- Reason
- 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
- 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
- 7,704 total, (5,594 in US & 2,110 OUS)
- Distribution
- worldwide
- Lot, serial or model codes
- Model 7277 InSync Marquis DR (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.) H-Series: PLT100002H - PLT100583H. S-Series: PLT600001S - PLT611901S.
- 510(k) numbers
- not on file
- PMA numbers
- ["P010031S003"]
- Product code
- NIK
- Firm FEI
- 2182208
- Firm city
- Fridley
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28