THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE 1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00813024010227), received between Feb 17, 2020 and Sep 1, 2026 — classified as 3 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (73 reports).

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 18, 2026.

Recalls naming this device

1. Aug 7, 2023Class IIOpen, Classified

   Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.

   Z-2658-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549416 ↗
• MalfunctionJun 24, 2026Dull, Blunt

  IT WAS REPORTED THAT THE APICAL CORING KNIFE WAS DULL. AFTER AN INITIAL ATTEMPT WITH THE CORING KNIFE, THE SURGEON USED KNIFE AND SCISSORS TO REMOVE APICAL CORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612872 ↗
• MalfunctionJan 19, 2026Dull, Blunt; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON DECIDED TO USE A STAND-ALONE CORING KNIFE DUE TO RECENT CONCERNS ABOUT THE DULLNESS OF THE CORING KNIFE IN THE IMPLANT KIT. THE STAND-ALONE CORING KNIFE WAS USED WITH NO ISSUES. THE CORING KNIFE IN THE IMPLANT KIT WAS BEING SENT BACK UNUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109372 ↗
• MalfunctionSep 22, 2025Dull, Blunt; Dull, Blunt

  DETAILS PROVIDED ON 17SEP2025 STATED THAT THE CORING PROCEDURE WAS ABLE TO BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23116299 ↗
• MalfunctionAug 14, 2025Mechanical Problem; Manufacturing, Packaging or Shipping Problem; Mechanical Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE OUTER EDGE OF THE CORING KNIFE FROM THE IMPLANT KIT HAD IMPERFECTIONS ALONG THE ENTIRE OUTER EDGE. A STAND-ALONE CORING KNIFE WAS OPENED AND HAD NO VISIBLE ISSUES. THE STAND-ALONE CORING KNIFE WAS USED IN THE FIELD WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808535 ↗
• MalfunctionJul 23, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON PREFERRED TO USE A STAND ALONG CORING WIFE DUE TO RECENT ISSUES WITH CORING KNIVES. THE KNIFE ONLY CUT THROUGH THE TOP LAYERS OF THE CARDIAC MUSCLE. SCISSORS WERE NEEDED TO REMOVE ALL OF THE CORE FROM THE VENTRICLE. NO HARM REACHED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579633 ↗
• MalfunctionJul 11, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING IMPLANTATION, THE APICAL CORING KNIFE WOULD NOT CUT THROUGH THE CARDIAC TISSUE TO CORE THE APEX. THE KNIFE CUT THROUGH THE TOP LAYERS OF CARDIAC TISSUE BUT HAD DIFFICULTY CORING AND THE SURGEON ENDED UP USING AN 11-BLADE TO FINISH CORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480066 ↗
• MalfunctionJul 9, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEONS AT THE SITE NOTED DIFFERENCES IN THE CORING KNIVES USED DURING RECENT IMPLANT SURGERIES. SCISSORS WERE USED TO FINISH CUTTING. THERE WERE OTHER FACTORS, SUCH AS VENTRICULAR CONDITION OR TRABECULAE, BUT THE SURGEONS WERE CONCERNED ABOUT DULL KNIVES. NO SPECIFIC DEVICE, PATIENT, OR EVENT DETAILS COULD BE PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457133 ↗
• MalfunctionJun 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY CORING THE APEX USING THE APICAL CORING KNIFE AND HAD TO USE MORE FORCE WHEN CORING. THE APEX WAS INTACT WITH CALCIFICATION. THE SURGEON HAD TO REMOVE EXTRA CARDIAC TISSUE THAT WAS NOT REMOVED WITH THE APICAL CORING KNIFE USING OTHER SURGICAL TOOLS. THERE WERE NO ISSUES WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359129 ↗
• MalfunctionMay 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DOCTOR HAD NOTICED SOME ABNORMALITIES IN THE SURFACE AREA OF THE DISTAL END OF THE CORING TOOL.THE TOOL WAS SUBSEQUENTLY USED HOWEVER, THERE WERE NO ISSUES WITH IT AS WELL. THE PHYSICIAN SUBSEQUENTLY KEPT THE TOOL FOR AN ANALYSIS IN-HOUSE AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115825 ↗
• MalfunctionMay 29, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE CORING KNIFE THAT WAS IN THE IMPLANTING KIT WAS DULL AND UNABLE TO CUT THROUGH THE LEFT VENTRICLE (LV) APEX DURING IMPLANT. THE DOCTOR TRIED MULTIPLE TIMES, BUT ULTIMATELY THE CORING KNIFE WAS EXCHANGED FOR ONE ON THE SHELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109759 ↗
• MalfunctionApr 3, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE CORING TOOL SEEMED DULL AND WAS UNABLE TO CUT THROUGH THE MYOCARDIUM AS EASILY AS IT SHOULD HAVE AND USUALLY DOES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762670 ↗
• MalfunctionJan 6, 2025Mechanical Problem; Dull, Blunt; Mechanical Problem; Dull, Blunt

  IT WAS REPORTED THAT DURING APICAL CORING, THE SURGEON COULD NOT OBTAIN A CLEAR CORE WITH THE CORING KNIFE AND COULD ONLY PARTIALLY CORE. THE CORING WAS COMPLETED WITH AN 11-BLADE KNIFE. THE VENTRICLE WAS NOT NOTED TO BE THICK AND THERE WAS NO THROMBUS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21082218 ↗
• MalfunctionDec 20, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON STATED THE APICAL CORING KNIFE WAS DULL. THE CORING KNIFE WAS UNABLE CORE THE VENTRICLE AND THE SURGEON USED A TRADITIONAL BLADE TO COMPLETE THE CORING NEEDED FOR LEFT VENTRICULAR ASSIST DEVICE (LVAD) INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20995697 ↗
• MalfunctionDec 10, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THE CORING KNIFE ENCLOSED IN THE SET WITH THE PUMP WAS NOT SHARP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893844 ↗
• MalfunctionOct 9, 2024Dull, Blunt; Dull, Blunt

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THE EVENT. THERE WAS NO DELAY IN SURGERY. A 11-BLADE SURGICAL SCALPEL WAS UTILIZED TO COMPLETE THE CORING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408655 ↗
• InjurySep 4, 2024Dull, Blunt; Dull, Blunt

  USER FACILITY MEDWATCH RECEIVED THAT STATES THE CORING KNIFE DID NOT CUT THROUGH, AND THE SURGEON HAD TO KEEP SCREWING. A MANUAL CUT WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 20136704 ↗
• MalfunctionAug 28, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE CORING KNIFE WAS DULL OUT OF BOX AND WAS UNABLE TO PENETRATE THE VENTRICLE. THE SURGEON STATED THEY APPLIED PRESSURE AND TRIED VERY HARD BUT THE KNIFE DID NOT CUT. VENTRICULOTOMY WAS CREATED WITH A SCALPEL AND SCISSORS. NO ADVERSE EFFECTS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085547 ↗
• MalfunctionAug 23, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT SURGEON WENT TO CORE LEFT VENTRICLE, AND THE CORING KNIFE DID NOT MAKE A COMPLETE CUT DESPITE COUNTER TENSION WITH FOLEY BALLOON. THE SURGEON QUESTIONED WHETHER THEY WERE HANDED THE DULL SIDE. IT NOTED BY AN OVERSEVERE OF THE CORING THAT IT WAS THE SHARP SIDE TOWARDS APEX OF LEFT VENTRICLE. THE SURGEON COMPLETED THE CORE WITH #11 BLADE. THE SURGEON WANTED THE CORING KNIFE EVALUATED. THE CORING KNIFE WAS IN THE IMPLANT KIT. THERE WAS NO HARM CAUSED TO THE PATIENT, NOR DELAY IN SURGERY. PER THE SURGEON, IT NEVER FELT NORMAL. THE KNIFE NEVER FELT LIKE IT WAS CUTTING. THE VENTRICLE WAS NOT THICK, NO MUSCLE INVOLVEMENT WHICH WAS CONFIRMED ON ECHOCARDIOGRAM BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048470 ↗
• MalfunctionJun 24, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE CORING KNIFE FROM THE IMPLANT KIT WAS BLUNT AND THE SURGEON WAS UNABLE TO PUNCH THE HEART MUSCLE WITH IT. THE REPLACEMENT STAND-ALONE CORING KNIFE WAS OPENED. HOWEVER, IT WAS ALSO FOUND TO BE BLUNT. THE SURGEON THEN USED SCISSORS AND A SCALPEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602609 ↗
• MalfunctionJun 24, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE CORING KNIFE FROM THE IMPLANT KIT WAS BLUNT AND THE SURGEON WAS UNABLE TO PUNCH THE HEART MUSCLE WITH IT. THE REPLACEMENT STAND-ALONE CORING KNIFE WAS OPENED. HOWEVER, IT WAS ALSO FOUND TO BE BLUNT. THE SURGEON THEN USED SCISSORS AND A SCALPEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602607 ↗
• MalfunctionMay 20, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT EVALUATION OF THE RETURNED CORING KNIFE REVEALED THAT THE CUTTING BLADE WAS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354439 ↗
• MalfunctionMay 20, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE EVALUATION OF THE RETURNED CORING KNIFE REVEALED THE CUTTING BLADE OF THE CORING KNIFE WAS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354157 ↗
• MalfunctionMay 16, 2024Mechanical Problem; Dull, Blunt; Mechanical Problem; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO COMPLETE THE CORE WITH THE HEARTMATE APICAL CORING KNIFE AND COMPLETED THE CORE WITH A SCALPEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330029 ↗
• InjuryApr 18, 2024Dull, Blunt; Infusion or Flow Problem; Dull, Blunt; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING THE PUMP-OFF PART OF THE IMPLANT ON (B)(6) 2024, WHICH WAS DONE VIA THE THORACOTOMY APPROACH WITH USE OF A FOLEY WITH BALLOON INFLATION OF 7 MLS FOR TENSION, ALONG WITH THE HEARTMATE APICAL CORING KNIFE. THE SURGEON NOTED THAT THE CORING DID NOT FEEL DIFFERENT THAN EXPECTED AND A ROUND PART OF THE LEFT VENTRICLE WAS REMOVED BEFORE THE PUMP WAS INSERTED. SHORTLY AFTER STARTING THE PUMP AT 12:20 PM, FLOWS DECREASED WITH LOW FLOW ALARMS DESPITE AN INCREASE IN PUMP SPEED. FLOWS THEN DROPPED TO 0.9 LPM WITH PUMP POWER AT 3.3 W AND SPEED AT 6000 RPM. AN ECHOCARDIOGRAM SHOWED NO FLOW THROUGH THE PUMP. THE PATIENT WAS PUT ON CARDIOPULMONARY BYPASS (CPB) AT 12:53 PM AND THE PUMP WAS TURNED OFF AT 12:54 PM. THE PUMP WAS UNLOCKED AND REMOVED, AND UPON INSPECTION OF THE LEFT VENTRICLE THE SURGEON NOTED THAT THE CORING KNIFE HAD NOT COMPLETELY CUT THROUGH THE LEFT VENTRICULAR APEX. THE REMAINING PORTION OF THE APEX WAS OBSTRUCTING THE INFLOW CANNULA, RESULTING IN LOWER FLOWS. THE REMAINING PORTION OF THE LEFT VENTRICLE WAS REMOVED WITH A SCALPEL AND THE PUMP WAS AGAIN PLACED INTO THE APICAL CUFF AND LOCKED IN PLACE. THE PUMP WAS TURNED ON AND PUMP SPEED WAS INCREASED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19137850 ↗