A&E Medical / Thorecon™ Auxiliary Cable Plate Kit (inc. screws & cable) 94-1500-04-SRecalls & reported problems
A & E Medical Corporation · Auxiliary Cable Plate Kit (inc. screws & cable, shp ndl) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841291107187), received between Mar 23, 2023 and Jun 3, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Packaging Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Packaging Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
- Wound Dehiscence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED THAT A HAIR WAS DISCOVERED IN THE INNER STERILE PACKAGING. THE IMPLANT WAS NOT USED. IT WAS REMOVED FROM THE STERILE FIELD, WIPED DOWN WITH ALCOHOL AND RETURNED TO ITS BOX. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19455978 ↗InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Wound Dehiscence
MAUDE report 16598317 ↗
Other Cable, Electrode devices
- N/A ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall1 report
- N/A ECG TRUNK CABLE, 6-LEAD, AHA, 1.2 M/4 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3/5-LEAD, AHA, 6 M/20 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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