AMC LW-341DS30/5ARecalls & reported problems
LifeSync Corporation · 5 Lead Disposable GE to Pinch, Shld, 30", OM Combiner, AHA · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849593015264), received between Sep 24, 2018 and Sep 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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.
Most reported problems
Device problems
- Defective Device1
- Scratched Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2018Defective Device; Scratched Material
WHEN OPENING A SET OF DISPOSABLE CARDIAC MONITOR CABLES, IT WAS NOTED THAT ONE OF THE CABLE WIRES WAS EXPOSED OUT OF THE COVERING FOR ABOUT 18 INCHES. CHECKED STOCK IN UNIT AND NO OTHER PACKAGES WITH THE SAME LOT# HAD DEFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901530 ↗
Other Cable, Transducer And Electrode, Patient, (Including Connector) devices
- IntraSight 797403Philips Image Guided Therapy Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)82 reports
- ASSY, CABLE, ECG, 15 LEAD, 3 WIRE PRECOR 11111Physio-Control, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)1 recall0 reports
- MR Patient Care Short Wide ECG 2.0 Cable AAMI CAB,4 LD,CV MRI ECGPhilips Ds North America LLC · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)12 reports
- NA 5492VLMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5492ALMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5487LMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)8 reports
- CORE M2 Vascular System 400-0100.17Volcano Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)6 reports
- NA 5487Medtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)6 reports
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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