Graftmaster 1012583-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648176487), received between Mar 28, 2017 and May 19, 2026 — classified as 3 deaths, 8 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION WHICH OCCURRED IN THE MID RIGHT CORONARY ARTERY (RCA), WHERE TWO UNSPECIFIED STENTS WERE OVERLAPPED. THE 3.5X26 AND 4.5X19 MM GRAFTMASTER COVERED STENTS WERE IMPLANTED AT 15 ATMOSPHERES AND SEALED THE PERFORATION. THE STENTS REPORTEDLY DID NOT CAUSE OR CONTRIBUTE TO ADVERSE EVENTS OR COMPLICATIONS; HOWEVER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25222878 ↗
• InjurySep 24, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIALLY FILED REPORTS IT WAS REPORTED THAT THE 4.5X19 MM GRAFTMASTER WAS DEPLOYED FIRST. THIS DID NOT COMPLETELY SEAL THE PERFORATION AND THE 4.0X19 MM GRAFTMASTER WAS THEN IMPLANTED AND THE PERFORATION WAS THOUGHT TO HAVE BEEN SEALED. THE IMPELLA PUMP WAS PLACED DUE TO HIGH END DIASTOLIC PRESSURE (EDP). WHEN THE PATIENT WAS BROUGHT BACK TO THE CATH LAB, THE 3.5X19 MM GRAFTMASTER WAS DEPLOYED. IN THE PHYSICIAN'S OPINION, NO GRAFTMASTER DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH AND THE PATIENT WAS DECLINING IN HEALTH (TOWARDS DEATH) PRIOR TO USE OF THE GRAFTMASTER DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension; Unspecified Heart Problem

  MAUDE report 23137787 ↗
• InjuryDec 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PERFORATION IN THE RIGHT CORONARY ARTERY. A 4.5X19MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 16 ATMOSPHERES, BUT THE PERFORATION WAS NOT SEALED. UNKNOWN INTERVENTION WAS PERFORMED TO TREAT THE PERFORATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988829 ↗
• 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 15914928 ↗
• InjuryJul 11, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE MID RIGHT CORONARY ARTERY. A 4.5X19MM RX GRAFTMASTER COVERED STENT WAS BEING ADVANCED BUT FAILED TO CROSS DUE TO ANATOMY. THEN A 3.5X19MM RX GRAFTMASTER WAS ADVANCED AND ALSO FAILED TO CROSS DUE TO ANATOMY. ANOTHER UNSPECIFIED COVERED STENT WAS USED TO SUCCESSFULLY SEAL THE PERFORATION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982136 ↗
• InjuryOct 26, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE LEFT MAIN/LEFT ANTERIOR DESCENDING ARTERIES. A 4.5X19MM AND 4X19MM RX GRAFTMASTER COVERED STENTS WERE DEPLOYED AT 16 ATMOSPHERES (ATM) AND 15 ATM, BUT FAILED TO SEAL THE PERFORATION. TYPE OF MEDICAL INTERVENTION WAS NOT SPECIFIED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, THE ACCOUNT CONFIRMED THAT THE 4X19MM RX GRAFTMASTER WAS FIRST IMPLANTED BUT FAILED TO SEAL THE PERFORATION. THERE WERE NO DEPLOYMENT ISSUES WITH THE STENT AND IT DID NOT EXACERBATE THE PERFORATION. THEN A 4.5X19MM RX GRAFTMASTER STENT WAS DEPLOYED AND ULTIMATELY SEALED THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12700159 ↗
• InjuryNov 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN A SAPHENOUS VEIN GRAFT (SVG) TO THE ACUTE MARGINAL TO RIGHT POSTERIOR DESCENDING (PDA) ARTERY. A 4.5X19MM RX GRAFTMASTER WAS DEPLOYED AT 16 ATMOSPHERES; HOWEVER FAILED TO SEAL PERFORATION INITIALLY. AFTER PROLONGED INFLATION THE GRAFTMASTER SEALED THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875806 ↗
• DeathJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A RIGHT CORONARY ARTERY (RCA) PERFORATION/ARTERY RUPTURE WITH HEMOPERICARDIUM WITH CARDIAC TAMPONADE. THE PATIENT HAD BECOME HEMODYNAMICALLY UNSTABLE AND BALLOON ANGIOPLASTY WAS PERFORMED, HOWEVER, THE BLEEDING CONTINUED. A 4.50X19MM (1012583-19, 8120441) A GRAFTMASTER STENT WAS IMPLANTED WITHOUT A DEVICE ISSUE REPORTED, SEALING THE PERFORATION. ON AN UNSPECIFIED DATE, A POSSIBLE SUBACUTE STENT THROMBOSIS OCCURRED AND THE PATIENT HAD EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Death; Thrombosis

  MAUDE report 10248729 ↗
• InjuryMay 24, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE CALCIFIED, PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH THE USE OF AN UNSPECIFIED DEVICE. A 4.50 X 19 MM GRAFTMASTER WAS IMPLANTED AT 16 ATMOSPHERE (ATM), BUT DID NOT FULLY SEAL THE PERFORATION, SO A 4.0 X 26 MM GRAFTMASTER WAS IMPLANTED INSIDE THE FIRST STENT AT 16 ATM, SUCCESSFULLY SEALING THE PERFORATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542834 ↗
• DeathAug 31, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE 3.5 X 19 MM (FIRST) AND 4.5 X 19 MM (SECOND) GRAFTMASTER RX STENTS WERE USED FOR TREATMENT OF A PERFORATION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. AFTER IMPLANTING THE FIRST GRAFTMASTER, THE PERFORATION WAS DISCOVERED TO BE LARGER THAN INITIALLY ANTICIPATED AND THE SECOND GRAFTMASTER WAS IMPLANTED. THE PATIENT SUBSEQUENTLY EXPIRED THE SAME DAY FROM CARDIOPULMONARY ARREST COMPLICATED BY HEMORRHAGE FROM PERFORATION AND ACUTE THROMBOTIC OCCLUSION OF THE GRAFTMASTER STENTS. THE PATIENT EXPIRED PRIOR TO SURGICAL REPAIR. IN THE OPINION OF THE PHYSICIAN, THE USE OF THE DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. NO AUTOPSY WAS PERFORMED. THE PATIENT'S HEALTH WAS DECLINING PRIOR TO GRAFTMASTER USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Death; Thrombosis

  MAUDE report 6836507 ↗
• InjuryMar 28, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RIGHT CORONARY ARTERY (RCA) PSEUDOANEURYSM LOCATED AT A PREVIOUS IMPLANTED RCA STENT AND WITH A CORONARY FEMORAL FISTULA INTO THE RIGHT ATRIUM. A 4.5X19MM GRAFTMASTER STENT WAS IMPLANTED WITHOUT REPORTED ISSUE IN THE PSEUDOANEURYSM AREA WITH THE PERFORATION. SUBSEQUENT ANGIOGRAPHY REVEALED IMPROVED BLOOD FLOW IN THIS AREA; HOWEVER, THERE WAS CONTINUED PSEUDOANEURYSM FORMATION. REPORTEDLY, THE PERFORATION WAS SEALED; HOWEVER, IT IS UNKNOWN IF THE GRAFTMASTER STENT CONTRIBUTED TO THE CONTINUED PSEUDOANEURYSM FORMATION. A 4.0X8MM NON-ABBOTT STENT WAS IMPLANTED IN THE MID RCA, OVERLAPPING THE PREVIOUS GRAFTMASTER STENT. ADDITIONALLY, A 4.0X8MM XIENCE ALPINE STENT WAS IMPLANTED OVERLAPPING THE DISTAL PORTION OF THE GRAFTMASTER STENT. POST DILATATION WAS PERFORMED ON THE ENTIRE STENTED PORTION. FINAL IMAGING REVEALED EXCELLENT STENT APPOSITION AND EXCLUSION OF THE PSEUDOANEURYSM AREA WITH BRISK ANTEGRADE FLOW DISTALLY. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADVERSE SEQUELA. PER PHYSICIAN, THE GRAFTMASTER STENT DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING T

  Patient problems: Pseudoaneurysm

  MAUDE report 6440349 ↗