Graftmaster 1012583-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648176470), received between Apr 11, 2017 and Mar 16, 2026 — classified as 1 death, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN AN UNSPECIFIED LESION. A 4.0X16 MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE IMPLANTED AT 12 ATMOSPHERES BUT IT WAS NOT REPORTED IF THE DEVICE SEALED THE PERFORATION. A 3.5X16 MM GRAFTMASTER WAS USED BUT IT WAS NOT REPORTED IF THE STENT WAS IMPLANTED. A 4.5X16 MM GRAFTMASTER COVERED STENT WAS USED BUT IT WAS NOT REPORTED IF THE STENT WAS IMPLANTED. THE PERFORATION WAS ULTIMATELY SEALED IN AN UNSPECIFIED WAY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607841 ↗
• InjuryFeb 16, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 4.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES (ATM) BUT THE PERFORATION WAS NOT SEALED. THEREFORE THE 3.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 20 ATM BUT THE PERFORATION WAS NOT SEALED. THE 2.8X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 18 ATM BUT AGAIN THE PERFORATION WAS NOT SEALED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24347591 ↗
• InjuryFeb 7, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE PROXIMAL RIGHT CORONARY ARTERY. THE 4.5X16MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO ANATOMY. THEREFORE, ANOTHER 4.0X16MM GRAFTMASTER WAS ATTEMPTED TO CROSS; HOWEVER, FAILED DUE RESISTANCE WITH ANATOMY. WHEN ATTEMPTING TO REMOVE THE GRAFTMASTER, IT WAS PULLED BACK A BIT, RESISTANCE WAS FELT WITH ANATOMY AND THE SHAFT SEPARATED. THE SEPARATED PORTION WAS EMBEDDED INTO THE VESSEL USING AN UNKNOWN DRUG COATED STENT. A THIRD 4.5X19MM GRAFTMASTER WAS USED SUCCESSFULLY TO COVER THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664492 ↗
• InjuryDec 5, 2022Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. AN IMPELLA DEVICE WAS PLACED. INTRAVASCULAR ULTRASOUND (IVUS) WAS ATTEMPTED ( TO ASSESS DISEASE BURDEN AND VESSEL SIZE) BUT WAS UNABLE TO PASS THE IVUS CATHETER INTO THE VESSEL BEYOND THE PROXIMAL PORTION. THERE WERE 2 AREAS OF DYE EXTRAVASATION WHICH WAS NOT INITIALLY OBVIOUS. BALLOON TAMPONADE WAS INITIALLY ATTEMPTED BUT UNSUCCESSFUL. THE 4.5X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 12 ATMOSPHERES (ATMS) BUT FAILED TO SEAL THE PERFORATION. A SECOND 4.5X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 12 ATMOSPHERES (ATMS) BUT ALSO FAILED TO SEAL THE PERFORATION. A THIRD 3.5X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED TO ENSURE COMPLETE COVERAGE BY THE FIRST 2 COVERED STENTS AT 12 ATMOSPHERES (ATMS) BUT STILL FAILED TO SEAL THE PERFORATION, HOWEVER, THE BLEEDING WAS IMPROVED CONSIDERABLY AND NO OTHER STENTS WERE DEPLOYED. THE GRAFTMASTER STENTS REPORTEDLY SHORTENED IN LENGTH THE FURTHER THEY WERE EXPANDED RADIALLY. IT IS POSSIBLE THAT FURTHER ATTEMPTS WITH BALLOON INFLATION MAY HAVE ACTUALLY SHORTENED THE LENGTH OF THE STENTS. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914883 ↗
• InjuryApr 2, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING ARTERY. TWO GRAFTMASTER STENTS (4.50X16MM AND 4.0X16MM) WERE IMPLANTED BUT THEY FAILED TO SEAL THE PERFORATION DUE TO LEAKS IN THE GRAFT. A 4.0X16MM GRAFTMASTER STENT WAS OPENED BUT IT WAS THEN NOTED THAT THE PERFORATION HAD SELF-SEALED, SO IT WAS NOT USED. AS THE PATIENT WAS BEING TRANSFERRED, HE STARTED BLEEDING AGAIN. TWO MORE GRAFTMASTER STENTS (4.0X16MM AND 4.0X16MM) WERE DEPLOYED BUT ALSO FAILED TO SEAL THE PERFORATION DUE TO GRAFT LEAKS AND THE PATIENT DIED. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS THE PERFORATION AND SHOCK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916334 ↗
• InjuryJan 3, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. FOLLOWING POST-DILATATION, THE PATIENT DEVELOPED A CORONARY PERFORATION, SO CPR WAS PERFORMED. A 4.5X26MM GRAFTMASTER COVERED STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY. A 3.5X16MM GRAFTMASTER COVERED STENT WAS DEPLOYED BUT WAS NOT CONFIRMED TO HAVE SEALED THE PERFORATION, SO A PERICARDIAL DRAIN WAS USED TO TREAT THE PERFORATION AS WELL. AN ATTEMPT TO INSERT AN IMPELLA WAS MADE BUT WAS UNSUCCESSFUL DUE TO THE ANATOMY. DESPITE FURTHER CPR, PATIENT IN PULSELESS ELECTRICAL ACTIVITY SHOWING NO PULSE, SO THE PATIENT WAS PRONOUNCED DEAD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547751 ↗
• MalfunctionOct 15, 2019Device Damaged by Another Device; Device Damaged by Another Device

  INITIAL INFORMATION RECEIVED VIA USER FACILITY MEDWATCH REGARDING A WIGGLE GUIDE WIRE STATES: WHEN ATTEMPTED TO REMOVE WIRE, THE TIP BROKE OFF AND BECAME ENTRAPPED BEHIND COVERED STENT. PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT EVENT AND RECOVERY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PROCEDURE WAS TO TREAT A FREE PERFORATION IN THE MID RIGHT CORONARY ARTERY (RCA). THE WIGGLE GUIDE WIRE WAS TRAPPED WHEN A GRAFTMASTER COVERED STENT WAS IMPLANTED. THE PERFORATION WAS SEALED. WHEN ATTEMPTING TO REMOVE THE WIRE THERE WAS SIGNIFICANT RESISTANCE AND THE TIP DETACHED. THE TIP WAS EMBEDDED TO THE VESSEL WALL BY THE USE OF AN ADDITIONAL STENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194893 ↗
• DeathJun 12, 2018Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT PRESENTED WITH HEART FAILURE AND NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI), AND WAS DEEMED NOT TO BE A SURGICAL CANDIDATE. THE PERFORATION COULD NOT BE SEALED AFTER FIVE GRAFTMASTER STENTS WERE DEPLOYED AT MAXIMUM PRESSURE (14 ATMOSPHERES). A 4.5 X 16 MM AND A 3.5 X 16 MM GRAFTMASTER STENT WERE IMPLANTED TO SEAL THE PERFORATION, BUT THE STENTS COULD NOT SEAL THE LARGE PERFORATION, AND THEREFORE ANOTHER 3.5 X 16 MM AND A 2.5 X 16 MM GRAFTMASTER STENTS WERE IMPLANTED INSIDE THE FIRST TWO STENTS TO HELP SEAL THE PERFORATION. A DECISION WAS MADE TO IMPLANT A FINAL STENT, A 2.5 X 16 GRAFTMASTER STENT TO ENSURE THE TARGET LESION WAS FULLY COVERED. HOWEVER, THE PATIENT'S VESSELS WERE SO FRAGILE THAT THE PROXIMAL AND MID LAD SPLIT OPEN AFTER ROTATIONAL ATHERECTOMY. THE PHYSICIAN REPORTED THAT THE PERFORATION WAS TOO LARGE AND THE PATIENT EXPIRED AS A RESULT OF THE ROTATIONAL ATHERECTOMY, AND NOT THE GRAFTERMASTER STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 7591387 ↗
• InjuryAug 23, 2017Positioning Failure

  IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE OSTIAL SAPHENOUS VEIN BYPASS TO DIAGONAL AND CIRCUMFLEX GRAFT WITH THE USE OF AN UNSPECIFIED DEVICE. THREE GRAFTMASTER STENTS WERE OPENED AND PREPARED. A 4.5 X 16 MM GRAFTMASTER WAS ATTEMPTED BUT THE STENT FAILED TO DEPLOY FROM THE BALLOON AFTER TWO ATTEMPTS TO INFLATE AT 18 ATMOSPHERE (ATM); THE DEVICE WAS REMOVED FROM THE ANATOMY. A 4.0 X 16 MM GRAFTMASTER STENT WAS IMPLANTED BUT FAILED TO ACHIEVE HEMOSTASIS AND A 4.5 X 19 MM GRAFTMASTER STENT WAS USED SUCCESSFULLY TO TREAT THE PERFORATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6814953 ↗
• MalfunctionApr 11, 2017Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2017 WAS TO TREAT A FISTULA IN THE DISTAL CAROTID ARTERY WITH HEAVY TORTUOSITY AND NO CALCIFICATION. A 4.5 X 16 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION BUT WOULD NOT CROSS AND THE SHAFT PEELING WAS OBSERVED DUE TO THE RESISTANCE WITH THE ANATOMY. A 4.0 X 16 MM GRAFTMASTER SDS WAS ADVANCED TO THE LESION WITH RESISTANCE AND THE BALLOON RUPTURED BETWEEN 7 AND 8 ATMOSPHERES WHICH RESULTED IN ONLY THE DISTAL AND PROXIMAL EDGES OF THE STENT EXPANDING. RESISTANCE WAS FELT DURING REMOVAL OF THE SDS DUE TO THE PARTIALLY EXPANDED IT COULD NOT BE PULLED BACK INTO THE GUIDE CATHETER. WHEN THE SDS WAS THREE QUARTERS OF THE WAY OUT OF THE CAROTID ARTERY, THE STENT IMPLANT DISLODGED FROM THE BALLOON AND WAS FREE FLOATING INSIDE THE VESSEL. THE STENT WAS SNARED AND REMOVED FROM THE PATIENT. THE PATIENT WAS STABLE AND THE LESION WAS LEFT UNTREATED. THE FOLLOW-UP PROCEDURE WAS PERFORMED ON (B)(6) 2017. A 4.5 X 16 MM GRAFTMASTER SDS WAS ADVANCED TO THE LESION; HOWEVER, IT WOULD NOT CROSS IT AND THE PROXIMAL SHAFT SEPARATED OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED AND A NEW 4.5 X 16 MM GRAFTMASTER STENT WAS SUCCESSFULLY DEPL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6481896 ↗