NA 11131 (REF 11131-000040)Recalls & reported problems
Physio-Control, Inc. · Sterilizable Internal Defibrillation Paddles, LP20 · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Aug 9, 2024Open, Classified
Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
Z-0142-2025 · Root cause: Under Investigation by firm · FDA record ↗
Other Dc-defibrillator, low-energy, (including paddles) devices
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall6 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall5 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall1 report
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- Internal Handle 1011-0139-05Zoll Medical Corporation · Dc-defibrillator, low-energy, (including paddles)17 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.