FDA Medical Device Recalls (openFDA)
Medtronic Physio Control Corp: LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-02-005003, DVLP12-02-000000 through DVLP12-02-005003, EVLP12-02-000000 through EVLP12-02-005003, FVLP12-02-000000 through FVLP12-02-005003, LVLP12-02-000000 through LVLP12-02-005003, PVLP12-02-000000 through PVLP12-02-005003, UVLP12-02-000000 through UVLP12-02-005003
- Recall number
- Z-1107-04
- Recalling firm
- Medtronic Physio Control Corp
- Product
- LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-02-005003, DVLP12-02-000000 through DVLP12-02-005003, EVLP12-02-000000 through EVLP12-02-005003, FVLP12-02-000000 through FVLP12-02-005003, LVLP12-02-000000 through LVLP12-02-005003, PVLP12-02-000000 through PVLP12-02-005003, UVLP12-02-000000 through UVLP12-02-005003
- Status
- Terminated
- Initiated
- 2004-05-05
- Posted
- 2004-07-20
- Terminated
- 2006-05-06
- Reason
- Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage.
- Root cause
- Other
- Action
- The firm reviewed records and/or contacted customers by telephone to verify affected devices used in the out of hospital mobile environment. All affected customers were notified by a letter dated May 2004. The firm''s service representative will contact customers to inspect and correct the devices.
- Quantity
- 20,676 domestic, 19,899 international
- Distribution
- The firm distributes to distributors, hospitals, EMT-Ds and paramedics nationwide. The firm also distibutes the product internationally.
- Lot, serial or model codes
- Non-continuous Serial Numbers between 1178083 and 305080962.
- 510(k) numbers
- ["K012274"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3015876
- Firm city
- Redmond
- Firm state
- WA
- 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