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NA 5846VLRecalls & reported problems

Medtronic, Inc. · CABLE 5846VL ROHS GLB 12FT 5PK 10L · Class 3

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169431621), received between Mar 20, 2023 and Aug 25, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Integrity Problem4
  • Connection Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • Tachycardia1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 25, 2023Connection Problem; Connection Problem

    THE PATIENT CABLE (VENTRICULAR) RETURNED FOR EVALUATION SUBSEQUENTLY TESTED OUT-OF-SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17622093 ↗
  • InjuryAug 8, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THERE WAS A LOSS OF PACING DURING USE DUE TO THE PATIENT CABLE BECOMING DETACHED FROM THE EXTERNAL PULSE GENERATOR (EPG). THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CABLE AND EPG WERE CHANGED OUT FOR AN ALTERNATIVE INSTRUMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: Tachycardia

    MAUDE report 17481237 ↗
  • MalfunctionJul 24, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE PATIENT CABLE WAS UNABLE TO CONNECT WITH THE JUMPER CABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17377381 ↗
  • MalfunctionJul 24, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE PATIENT CABLE WAS UNABLE TO CONNECT WITH THE JUMPER CABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17376744 ↗
  • MalfunctionMar 20, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE COMPETITOR PACER CATHETER WAS NOT HOOKING WELL INTO THE CABLE. IT WAS NOTED THAT A TIGHTNESS WAS FELT WHEN PUSHING DOWN THE RED AND BLACK PIN AND IT DID NOT 'CLICK' AS PREVIOUSLY. IT WAS NOTED THAT THE ISSUE WAS OBSERVED WHEN THE CABLE WAS BEING CONNECTED TO THE PACING CATHETER AND PRIOR TO INSERTION OF THE PATIENT CATHETER INTO THE PATIENT¿S BODY . THE CUSTOMER WAS CONCERNED THAT GOOD CONTACT WAS NOT BEING MADE HOWEVER IT WAS NOTED THAT THE PACING CATHETER AND CABLES STILL FUNCTIONED WITH NO COMPLAINT OF FAILURE. THE CABLE WAS RECEIVED INTO SERVICE AND SUBSEQUENTLY TESTED OUT-OF-SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16572271 ↗

Other Implantable pulse generator, pacemaker (non-CRT) devices

All Implantable pulse generator, pacemaker (non-CRT) devices →

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