Physio-control Corp.
FDA adverse event reports naming Physio-control Corp. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: PHYSIO-CONTROL CORP..
- Total reports
- 1,374
- Deaths
- 131
- Injuries
- 56
- Malfunctions
- 1,161
Reports per year
Source: FDA adverse event reports by year received, 1993–2002. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Dc-Defibrillator, Low-Energy, (Including Paddles)LDD1,020
- Automated External Defibrillators (Non-Wearable)MKJ294
- Electrode, Electrocardiograph, Multi-FunctionMLN41
- Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)DRO11
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT3
- Pulse-Generator, Pacemaker, ExternalDTE2
- Electrode, Pacemaker, TemporaryLDF2
- Product code 1
- Dc-Defibrillator, High Energy, (Including Paddles)DRK1
- Cable, Transducer And Electrode, Patient, (Including Connector)DSA1
Recent recalls
- 2004-07-20TerminatedOther
LIFEPAK 500 automated external defibrillator
Potential for batteries to malfunction due to battery cell rupture.
- 2004-07-20TerminatedOther
LIFEPAK 12 defibrillator/monitor.
Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
- 2004-07-20TerminatedOther
DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor.
The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor.
- 2004-07-20TerminatedOther
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
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.
- 2004-01-06TerminatedOther
LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.
Device unable to recognize the connection to the hard paddles accessory.
- 2003-06-12TerminatedOther
LIFEPAK CR Plus defibrillator
Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
- 2003-02-05TerminatedOther
LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually defibrillate, or automatically analyze and if necessary, defibrillate a patient through therapy cables with disposable electrodes, standard paddles, or internal handle cables. Product is labeled with ''Medtronic Physio-Control, Redmond, WA''
Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.
Monitor Physio-control Corp. automatically
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