HVAD® Pump Surgical Tools 1318Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888707000154), received between Jul 29, 2016 and Dec 8, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Contamination” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DRIVELINE COVER WAS STUCK. A DRIVELINE COVER REMOVAL PROCEDURE WAS PERFORMED AND THE DRIVELINE COVER WAS EX CHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15944065 ↗
• MalfunctionApr 28, 2021Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD)'S DRIVELINE (DL) COVER RUBBER BOOT WAS HARDEN AND UNABLE TO BE RETRACTED AND MANEUVERED. THE DL BOOT COVER WAS WIGGLED AND PULLED ON FOR A FEW MINUTES AND THEN IT WAS ABLE TO RETRACT. THE BOOT COVER WAS CUT OFF AND A NEW RUBBER BOOT WAS PLACED ON WITH MINIMAL VAD TIME OFF. THE VAD'S DRIVELINE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738608 ↗
• MalfunctionAug 25, 2020Contamination; Contamination

  IT WAS REPORTED THAT THE HEX DRIVER WAS CONTAMINATED DURING PROCEDURE. THE HEX DRIVER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448250 ↗
• MalfunctionDec 20, 2019Contamination; Contamination

  IT WAS REPORTED THAT DURING THE VENTRICULAR ASSIST DEVICE (VAD) IMPLANT PROCEDURE, THE TUNNELER WAS CONTAMINATED. THE TUNNELER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9500674 ↗
• MalfunctionDec 11, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE, THE PUMP WAS BEING ASSEMBLED AND THE OUTFLOW GRAFT STRAIN RELIEF WAS UNABLE TO BE PROPERLY PLACED OR TIGHTENED ONTO THE OUTFLOW CANNULA, AS IT WAS NOT ¿CLICKING IN PLACE¿ NOR WERE THE CLAMPS ABLE TO FLUSH TOGETHER TO CREATE A PROPER SEAL. AFTER MULTIPLE ATTEMPTS, IT WAS DETERMINED THAT THE ISSUE WAS IN THE OUTFLOW GRAFT STRAIN RELIEF. A NEW IMPLANT ACCESSORIES KIT WAS OPENED AND THE OUTFLOW GRAFT STRAIN RELIEF WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9451545 ↗
• MalfunctionApr 10, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, DURING IMPLANT, THAT THE VENTRICULAR ASSIST DEVICE (VAD) APEX CORING TOOL WAS NOT CUTTING THE TISSUE EASILY. THE TOOL WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7414191 ↗
• MalfunctionFeb 26, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHILE USING A TUNNELING ROD TO TUNNEL THROUGH THE PATIENT¿S ABDOMEN, THE ROD WAS BENT BY THE SURGEON AND IT SNAPPED IN HALF. THE SURGEON WAS ABLE TO FEED THE ROD THROUGH THE PATIENT¿S ABDOMEN TO CONNECT THE DRIVELINE AND SUCCESSFULLY PULLED THE DRIVELINE THROUGH THE PATIENT¿S ABDOMEN. A PROVIDED PICTURE APPEARS TO CONFIRM THE REPORTED BREAK. THE DEVICE WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7296314 ↗
• MalfunctionJul 29, 2016Material Frayed; Device Contamination with Chemical or Other Material; Material Frayed; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SURGEON THAT IT WAS NOTED THAT THERE WAS DIFFICULTY IN CORING THE LEFT VENTRICULAR APEX. THE CORING TOOL WAS INSPECTED AND WAS NOTED TO HAVE A "JAGGED EDGE". THE PATIENT WAS STABLE POST-IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5834899 ↗