FDA Medical Device Recalls (openFDA)
Medtronic Inc. Cardiac Rhythm Managment: Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx
- Recall number
- Z-0811-04
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- Product
- Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx
- Status
- Terminated
- Initiated
- 2004-04-02
- Posted
- 2004-07-20
- Terminated
- 2005-11-29
- Reason
- Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.
- Root cause
- Other
- Action
- A letter, dated April 2004, was sent on April 5, 2004 to physicians following patients who had the defibrillators implanted. The letter gave recommendations to physicians for selective replacement of some of the implanted devices and for avoiding the problem. Physicians are being visited by sales representatives to verify notification.
- Quantity
- 5839 units (2394 units in the United States)
- Distribution
- Nationwide in the United States and worldwide.
- Lot, serial or model codes
- Manufacturing dates from November 1996 to December 1997; and Use Before Dates from May 1998 to June 1999.
- 510(k) numbers
- not on file
- PMA numbers
- ["P900061/S24"]
- Product code
- LWS
- 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