Driveline Extension Cable 100USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888707000024), received between Mar 19, 2018 and Jul 15, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 3, 2021Class IOpen, Classified

   Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

   Z-2193-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2021Misassembly by Users; Misassembly by Users

  IT WAS REPORTED THAT DURING WET TEST THE DRIVELINE EXTENSION CABLE WAS MISSING THE RED DOT WHICH INDICATES WHERE TO LINE IT UP WITH THE VENTRICULAR ASSIST DEVICE (VAD) DRIVELINE CABLE. THE DRIVELINE EXTENSION CABLE WORKED FINE DURING WET TEST AND HAS BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174918 ↗
• MalfunctionSep 13, 2019Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING OF THE DRIVELINE EXTENSION CABLE WAS COMPROMISED. THE PRODUCT WAS NOT STERILE AND HAD BEEN RECEIVED IN THE HOSPITAL IN THAT CONDITION. THE DRIVELINE EXTENSION CABLE WAS NOT USED AND TAKEN OUT OF SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9034504 ↗
• MalfunctionJun 10, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  THE DRIVELINE EXTENSION CABLE WAS RETURNED DUE TO THE EXPIRATION DATE ON THE PACKAGING BEING TWO MONTHS PRIOR THAN THE ACTUAL EXPIRATION DATE. THE DRIVELINE EXTENSION CABLE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8684061 ↗
• MalfunctionApr 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) DRIVELINE EXTENDER CABLE MALFUNCTIONED. THE DRIVELINE EXTENDER IS NO LONGER IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441368 ↗
• MalfunctionApr 6, 2018Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) DRIVELINE SHEATH EXHIBITED DAMAGE THAT HAD BEEN PREVIOUSLY REPAIRED. THE DRIVELINE SHEATH WAS REPAIRED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7403713 ↗
• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS HOSPITALIZED WITH SYMPTOMS OF FEVER, CHILLS, RIGOR AND MALAISE. PATIENT HAD A DRIVELINE INFECTION, CULTURES TESTED (B)(6) FOR BACTERIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chills; Fever; Malaise; Unspecified Infection

  MAUDE report 7350935 ↗