NA 5846AL (UDI 00643169431669)Recalls & reported problems
Medtronic, Inc. · CABLE 5846AL ROHS GLB 12FT 5PK 10L · Class 3
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169431669), received between May 9, 2022 and Oct 16, 2023 — classified as 1 injury, 17 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (18 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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem18
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Ventricular Fibrillation1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PATIENT CABLE DID NOT HAVE AN OPTIMAL CONNECTION WITH THE PACING CATHETER. IT WAS NOTED THAT IT WAS NOT POS SIBLE TO FULLY INSERT THE CATHETER CONNECTORS INTO THE PATIENT CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17937615 ↗MalfunctionSep 21, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SURGICAL CABLE WAS UNABLE TO CLICK AND STAY IN PLACE IN THE EXTERNAL PULSE GENERATOR (EPG), HENCE THE EPG WAS UNABLE TO PACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17794618 ↗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 17377330 ↗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 17377093 ↗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 17377038 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
THE PATIENT CABLE (ATRIAL) WAS UNABLE TO CONNECT WITH THE ADAPTER CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984994 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SURGICAL CABLES WERE UNABLE TO CONNECT WITH THE ADAPTER CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984967 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SURGICAL CABLES WERE UNABLE TO CONNECT WITH THE ADAPTER CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984922 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
THE PATIENT CABLE (ATRIAL) WAS UNABLE TO CONNECT WITH THE ADAPTER CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984893 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SURGICAL CABLES WERE UNABLE TO CONNECT WITH THE ADAPTER CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984814 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SURGICAL CABLES WERE UNABLE TO CONNECT WITH THE ADAPTER CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984253 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SURGICAL CABLES WERE UNABLE TO CONNECT WITH THE ADAPTER CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984125 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SURGICAL CABLES WERE UNABLE TO CONNECT WITH THE ADAPTER CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984033 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
THE PATIENT CABLE (ATRIAL) WAS UNABLE TO CONNECT WITH THE ADAPTER CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984003 ↗MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SURGICAL CABLES WERE UNABLE TO CONNECT WITH THE ADAPTER CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16983966 ↗InjuryNov 2, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CABLE'S CONNECTORS WERE TOO SMALL TO DELIVER TEMPORARY PACING AND AS A RESULT A PATIENT ALMOST REQUIRED A SHOCK DUE TO POLYMORPHIC VENTRICULAR TACHYCARDIA (PMVT). THE PATIENT SUFFERED VENTRICULAR FIBRILLATION AND MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Ventricular Fibrillation
MAUDE report 15714659 ↗MalfunctionJul 13, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CABLE WAS NOT ABLE TO CORRECTLY CONNECT TO THE EXTERNAL PULSE GENERATOR (EPG). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14998143 ↗MalfunctionMay 9, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CABLE WOULD NOT TIGHTLY CONNECT TO THE PACING CATHETER OR STAY IN PLACE. AN ALTERNATIVE CABLE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14336802 ↗
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- ACCOLADE™ MRI DR L311Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls59 deaths7,283 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)107 deaths5,971 reports
- ACCOLADE™ DR L301Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls6 deaths2,513 reports
- ACCOLADE™ EL DR L321Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls2 deaths1,906 reports
- ACUITY™ X4 Spiral S 4674Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 deaths1,975 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.