Zoll Lifecor Corporation
FDA adverse event reports naming Zoll Lifecor Corporation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ZOLL LIFECOR CORPORATION.
- Total reports
- 13,706
- Deaths
- 165
- Injuries
- 12
- Malfunctions
- 13,522
Reports per year
Source: FDA adverse event reports by year received, 2004–2015. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Wearable Automated External DefibrillatorMVK13,683
- Automated External Defibrillators (Non-Wearable)MKJ17
- Dc-Defibrillator, Low-Energy, (Including Paddles)LDD2
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW2
- Product code ------1
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH1
Recent recalls
- 2010-12-16TerminatedOther
Model 4000 Monitor component of the LifeVest Wearable Defibrillator
The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.
- 2009-01-28TerminatedComponent design/selection
Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
The charging circuit will not shut down properly.
- 2007-10-18TerminatedDevice Design
Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.
- 2007-06-15TerminatedOther
Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.
The electrodes do not properly release conductive gel
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