Valleylab E0560Recalls & reported problems
Covidien LP · REM (TM) Patient Return Electrode Cord · Class 2
All models of Valleylab (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884524001791), received between May 10, 2019 and Nov 15, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Alarm System1
Patient problems
- Burn(s)3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 16, 2021Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A TOTAL HIP REPLACEMENT PROCEDURE, A NON-MEDRONIC REM POLE PLATE ALARMED WHEN USING A MEDTRONIC REM CORD AND GENERATOR DEVICE. THE PATIENT HAD POLE PLATE ELECTRIC BURNED ON CALF DURING THE NURSE'S EXAMINATION WHICH WAS ALSO UNDER GENERAL ANESTHESIA. THE BURN SIZE WAS LARGE ESTIMATED TO BE THE SIZE OF A 1 YUAN COIN BUT WAS SHOWN THE BURN WAS SERIOUS, SINCE THE PICTURE OF THE PATIENT'S BURN COULD NOT BE SEEN, IT WAS IMPOSSIBLE TO DETERMINE THE DEGREE OF THE PATIENT'S BURN. THE DOCTOR DID NOT WANT TO DISCLOSE THE TREATMENT METHOD USED. A PHOTO WAS ATTACHED SHOWING THE REM PAD WITH BLACK BURN SITE. GENERATOR HAS NO CONTRIBUTORY FACTOR/CAUSAL RELATIONSHIP TO THE BURN ISSUE.
Patient problems: Burn(s)
MAUDE report 12012596 ↗MalfunctionMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THERE WAS A SKIN BURN SIMILAR TO A COIN SIZE IN THE ABDOMEN. THE BURN WAS TREATED WITH A DRESSING WITH DRUGS.
Patient problems: Burn(s)
MAUDE report 8600409 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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