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NA FL-601-97Recalls & reported problems

Remington Medical, Inc. · 6 Foot Disposable Extension Cable with Safe Connect / Screw-Down · Class 2

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 00813079021285), received between Apr 4, 2023 and Apr 4, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Ejection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Unintended Ejection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 4, 2023Unintended Ejection; Unintended Ejection

    COMPLAINANT REPORTED THAT THE ICU STAFF HAD A PROBLEM WITH THE FL-601-97 DISPOSABLE CABLE. IT COULD BE INSERTED INTO THE OUTLET ON THE EPG DEVICE, BUT IT WOULD NOT SNAP INTO PLACE AND REMAIN FIRMLY CONNECTED. ANOTHER DISPOSABLE CABLE WAS ATTACHED AND HAD NO PROBLEMS. AS REPORTED BY USER FACILITY: "PATIENT HAD A TEMPORARY PACEMAKER, AND DISLODGE THE CABLES FROM THE PACER BOX. WHEN THE CABLES WERE TESTED, THEY DID NOT CLICK INTO A LOCK POSITION DUE TO A DEFECT. THE CABLES WERE REPLACED. A 55 YEAR OLD MALE UNDERWENT DOUBLE VALVE AND CORONARY ARTERY BYPASS (B)(6) 2023. TWO TEMPORARY RIGHT VENTRICULAR PACER WIRES WERE IN PLACED, AND CONNECTED TO TEMPORARY PACER BOX AFTER SURGERY." TWELVE CABLES WERE RETURNED TO THE MANUFACTURER BY THE USER FACILITY. THE RETURNED "OPENED" CABLE WAS TESTED FOR FIT INTO A STANDARD FEMALE CONNECTOR. THIS ONE CABLE DID NOT LOCK INTO PLACE AS DESIGNED, CONFIRMING THE COMPLAINANT'S OBSERVATION. THE ELEVEN "UNOPENED" RETURNED CABLES WERE ALSO FIT TESTED. ALL ELEVEN CABLES FIT (LOCKED INTO THE FEMALE CONNECTOR) PROPERLY AS DESIGNED. THE ONE CABLE THAT DID NOT LOCK INTO PLACE APPEARS TO BE A ONE-TIME EVENT IN WHICH THE LOCKING TAB ON THE CONNECTOR SHROUD WAS BENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16673675 ↗

Other CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.