EDGE Electrodes with REDI-PAK™ Preconnect System 11996Recalls & reported problems
Physio-Control, Inc. · ELECT ASSY-EDGE,QUIK-COMBO REDI-PAK,WW · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00681490580656), received between Jan 19, 2022 and Jan 19, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (3 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Peeled/Delaminated3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2022Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED THAT THE ELECTRODE EXHIBITED DELAMINATION. PER ADDITIONAL INFORMATION RECEIVED, THE DELAMINATION OCCURRED BEFORE USE ON THE PATIENT AND THERE WAS NO IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13294331 ↗MalfunctionJan 19, 2022Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED THAT THE ELECTRODE EXHIBITED DELAMINATION. PER ADDITIONAL INFORMATION RECEIVED, THE DELAMINATION OCCURRED BEFORE USE ON THE PATIENT AND THERE WAS NO IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13294243 ↗MalfunctionJan 19, 2022Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED THAT THE ELECTRODE EXHIBITED DELAMINATION. PER ADDITIONAL INFORMATION RECEIVED, THE DELAMINATION OCCURRED BEFORE USE ON THE PATIENT AND THERE WAS NO IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13294227 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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