Graftmaster 1012583-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648176494), received between May 15, 2017 and Nov 6, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PSEUDOANEURYSM IN THE RIGHT CORONARY ARTERY. A 4.5X26MM GRAFTMASTER COVERED STENT WAS DEPLOYED AND POST DILATION WAS PERFORMED WITH A 4.5X12MM NON-ABBOTT BALLOON. IT WAS NOTED THAT THE STENT WAS EXPIRED. A 4.0X16MM GRAFTMASTER COVERED STENT WAS DEPLOYED SUCCESSFULLY AND POST DILATATION WAS PERFORMED WITH A 4X8MM NON-ABBOTT BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487654 ↗
• InjurySep 23, 2021Off-Label Use; Failure to Advance; Off-Label Use; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST ELEVATION MYOCARDIAL INFARCTION AND CARDIAC ARREST. MILD EXTRAVASATION WAS NOTED AROUND AN OLD COVERED STENT, WHICH WAS IMPLANTED ON (B)(6) 2017, GOING INTO A PRE-EXISTING PROXIMAL ANEURYSM IN THE SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL. A 4.0X26MM GRAFTMASTER STENT SYSTEM WAS ADVANCED FOR TREATMENT OF THE ANEURYSM, BUT AFTER A LOT OF MANIPULATING, FAILED TO REACH THE ANEURYSM. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE STENT WAS DISLOCATED AND THE DELIVERY SYSTEM WAS TORN AND STRETCHED. NEXT THE 4.5X26MM GRAFTMASTER STENT SYSTEM WAS ADVANCED FOR TREATMENT OF THE ANEURYSM, BUT FAILED TO REACH THE ANEURYSM. THERE WAS EVIDENCE OF WORSENING EXTRAVASATION INTO THE ANEURYSM. TRANSIENT NO FLOW WAS NOTED. BALLOON ANGIOPLASTY WAS PERFORMED FOR ONE MINUTE AND IMPROVED THE TRANSIENT NO FLOW. A NON-ABBOTT STENT WAS IMPLANTED, SUCCESSFULLY RESOLVING THE ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED. .

  Patient problems: Perforation of Vessels

  MAUDE report 12523744 ↗
• InjuryJan 2, 2020Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE 4.5X26 MM GRAFTMASTER STENT WAS USED OFF LABEL TO TREAT A RUPTURED PSEUDO-ANEURYSM IN THE SUPERIOR MESENTERIC ARTERY. THE GRAFTMASTER SUCCESSFULLY SEALED THE ANEURYSM, BUT THROMBUS WAS NOTED IN THE ILEOCOLIC ARTERY AFTER STENT IMPLANTATION. MEDICATION (TPA) WAS ADMINISTERED VIA INJECTION IN THE ARTERY TO TREAT THE THROMBUS AND THE THROMBUS RESOLVED. THE PATIENT WAS A DO NOT RESUSCITATE STATUS. THE PATIENT EXPIRED OF LIVER FAILURE ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9538496 ↗
• InjuryJan 17, 2018Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION CAUSED BY A SMALL SEMI-COMPLIANT BALLOON IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE GRAFTMASTER 4.5 X 26 MM STENT FAILED TO CROSS DUE TO THE PATIENT ANATOMY. A BALLOON WAS USED TO SEAL THE PERFORATION, THEN COVERED WITH A DRUG-ELUTING STENT. THERE WERE NO OTHER COMPLICATIONS DUE TO THE NO CROSS. THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX. THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO ANY COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7202493 ↗
• InjuryMay 15, 2017Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND A LARGE, SEVERELY STENOSED, CONTAINED PERFORATION (PSEUDOANEURYSM) IN A DEGENERATED SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL (OM) CORONARY ARTERY. GIVEN THE HIGH RISK OF VESSEL RUPTURE WITH STANDARD PERCUTANEOUS CORONARY INTERVENTION AND DUE TO THE LARGE SIZE OF THE PERFORATION, TWO COVERED STENTS WERE OPTED FOR TREATMENT OF THE PSEUDOANEURYSM TO ENSURE COMPLETE COVERAGE. THUS, A 4.5X26MM RX GRAFTMASTER WAS ADVANCED VIA RIGHT FEMORAL ARTERY ACCESS AND WAS DEPLOYED, FOLLOWED BY OVERLAPPING DEPLOYMENT OF A 4.0X19MM RX GRAFTMASTER COVERED STENT. EACH GRAFTMASTER SUCCESSFULLY SEALED THE AREA IT WAS DEPLOYED IN AND DID NOT EXACERBATE THE PSEUDOANEURYSM. THE GRAFTMASTERS WERE POST-DILATED WITH AN UNSPECIFIED 5.0MM BALLOON. WHILE INTRAVASCULAR ULTRASOUND (IVUS) SHOWED THAT THE GRAFTMASTER STENTS WERE WELL EXPANDED, A PROXIMAL EDGE DISSECTION (AT THE IMPLANTED 4.0X19MM RX GRAFTMASTER) WAS NOTED AND WAS SUCCESSFULLY TREATED VIA DEPLOYMENT OF AN UNSPECIFIED 4.0X22MM DRUG-ELUTING STENT. THE PATIENT THEN EXPERIENCED TRANSIENT NO REFLOW DUE TO MICROVASCULAR OBSTRUCTION WHICH WAS TREATED WITH INTRA GRAFT NIPRIDE (BLOOD

  Patient problems: Ischemia; Non specific EKG/ECG Changes

  MAUDE report 6567991 ↗