GraftmasterRecalls & reported problems across all models

We found 15 models of Graftmaster by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 1,071 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2016 and Aug 10, 2026 — classified as 161 deaths, 801 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (410 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Graftmaster problems

Graftmaster models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Graftmaster 1012580-16

  coronary covered stent
  39 deaths233 reports
• Graftmaster 1012580-19

  CATHETER, FLOW DIRECTED
  30 deaths225 reports
• Graftmaster 1012581-16

  CATHETER, FLOW DIRECTED
  21 deaths147 reports
• Graftmaster 1012581-19

  CATHETER, FLOW DIRECTED
  12 deaths135 reports
• Graftmaster 1012582-19

  CATHETER, FLOW DIRECTED
  13 deaths77 reports
• Graftmaster 1012580-26

  CATHETER, FLOW DIRECTED
  13 deaths72 reports
• Graftmaster 1012582-16

  coronary covered stent
  9 deaths68 reports
• Graftmaster 1012581-26

  CATHETER, FLOW DIRECTED
  13 deaths53 reports
• Graftmaster 1012582-26

  coronary covered stent
  6 deaths22 reports
• Graftmaster 1012583-19

  CATHETER, FLOW DIRECTED
  3 deaths11 reports
• Graftmaster 1012583-16

  coronary covered stent
  1 death10 reports
• Graftmaster 1012583-26

  CATHETER, FLOW DIRECTED
  5 reports
• Graftmaster 1012584-16

  coronary covered stent
  5 reports
• Graftmaster 1012584-26

  coronary covered stent
  5 reports
• Graftmaster 1012584-19

  CATHETER, FLOW DIRECTED
  1 death3 reports

Recent Graftmaster adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193057 ↗
• InjuryJul 13, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.0X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED HOWEVER IT FAILED TO SEAL THE PERFORATION. A SECOND GRAFTMASTER WAS IMPLANTED TO COMPLETELY SEAL THE PERFORATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25795960 ↗
• InjuryJun 25, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT OCCURRED AFTER STENTING WITH A NON-ABBOTT 3.5X26 MM DRUG ELUTING STENT. A NON-ABBOTT STENT WAS DEPLOYED AND SERIAL POST DILATATION WAS PERFORMED BUT THERE WAS CONTINUED BLEEDING. THE PATIENT BEGAN EXPERIENCING HYPOTENSION DESPITE FLUID BOLUSES. NOREPINEPHRINE WAS PROVIDED AND PERICARDIOCENTESIS WAS PERFORMED WITH ECHOCARDIOGRAPHY CONFIRMING A RAPIDLY DEPLOYING EFFUSION WITH RIGHT VENTRICLE COLLAPSE CONSISTENT WITH CARDIAC TAMPONADE. BEFORE PLACEMENT OF THE PERICARDIAL DRAIN, AN AGITATED SALINE STUDY WAS PERFORMED CONFIRMING LOCATION AND THE 3.5X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES. THIS STENT DID NOT SEAL THE PERFORATION SO A 4.0X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES OVERLAPPING THE FIRST GRAFTMASTER. DESPITE MULTIPLE INFLATIONS THE BLEEDING CONTINUED AND INFLATION WAS PERFORMED WITH A 4.0 MM NC NON-ABBOTT BALLOON FOR 30 SECOND EPISODES. THERE WERE TWO EPISODES OF POLYMORPHIC VENTRICULAR TACHYCARDIA AND ELECTRICAL CARDIOVERSION WAS PERFORMED. THE PATIENT WAS STRUGGLING WITH DYSPNEA, DISCOMFORT AND NAUSEA. AFTER R

  Patient problems: Dyspnea; Nausea; Pain; Tachycardia

  MAUDE report 25627337 ↗
• InjuryJun 25, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT OCCURRED AFTER STENTING WITH A NON-ABBOTT 3.5X26 MM DRUG ELUTING STENT. A NON-ABBOTT STENT WAS DEPLOYED AND SERIAL POST DILATATION WAS PERFORMED BUT THERE WAS CONTINUED BLEEDING. THE PATIENT BEGAN EXPERIENCING HYPOTENSION DESPITE FLUID BOLUSES. NOREPINEPHRINE WAS PROVIDED AND PERICARDIOCENTESIS WAS PERFORMED WITH ECHOCARDIOGRAPHY CONFIRMING A RAPIDLY DEPLOYING EFFUSION WITH RIGHT VENTRICLE COLLAPSE CONSISTENT WITH CARDIAC TAMPONADE. BEFORE PLACEMENT OF THE PERICARDIAL DRAIN, AN AGITATED SALINE STUDY WAS PERFORMED CONFIRMING LOCATION AND THE 3.5X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES. THIS STENT DID NOT SEAL THE PERFORATION SO A 4.0X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES OVERLAPPING THE FIRST GRAFTMASTER. DESPITE MULTIPLE INFLATIONS THE BLEEDING CONTINUED AND INFLATION WAS PERFORMED WITH A 4.0 MM NC NON-ABBOTT BALLOON FOR 30 SECOND EPISODES. THERE WERE TWO EPISODES OF POLYMORPHIC VENTRICULAR TACHYCARDIA AND ELECTRICAL CARDIOVERSION WAS PERFORMED. THE PATIENT WAS STRUGGLING WITH DYSPNEA, DISCOMFORT AND NAUSEA. AFTER R

  Patient problems: Dyspnea; Nausea; Pain; Tachycardia

  MAUDE report 25627011 ↗
• InjuryJun 25, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CORONARY PERFORATION. THE 4.0X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED BUT DID NOT SEAL THE PERFORATION. ANOTHER 4.0X16 MM GRAFTMASTER WAS IMPLANTED AND SEALED THE PERFORATION AFTER PROLONGED POST DILATATION. THE DEVICES DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25625028 ↗
• 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 ↗
• MalfunctionMay 13, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RUPTURE [PERFORATION] IN THE LEFT MAIN CORONARY ARTERY. THE 2.8X16MM GRAFTMASTER STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, THE STENT WAS NOTED TO BE EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED DUE TO THE IMPLANTATION OF THE GRAFTMASTER STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165322 ↗
• 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 24607923 ↗
• 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 ↗
• 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 24607809 ↗
• InjuryMar 5, 2026Difficult or Delayed Positioning; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A PERFORATION IN THE OSTIAL PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND DISTAL LEFT MAIN TRUNK (LMT) ARTERIES. THE 4.8X16M GRAFTMASTER COVERED STENT WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED; HOWEVER, POST DEPLOYMENT THE SHAFT SEPARATED DURING REMOVAL IN THE AORTA. THE SEPARATED BALLOON WAS SNARED FROM THE PATIENT, WHICH CAUSED A CLINICALLY SIGNIFICANT DELAY IN TREATING A NOTED RESIDUAL LEAK WHERE THE STENT WAS IMPLANTED. THE PATIENT WENT INTO SHOCK, RESPIRATORY FAILURE AND PERICARDIAL EFFUSION WAS NOTED WHICH REQUIRED PERICARDIOCENTESIS AND AN IMPELLA DEVICE. ANOTHER GRAFTMASTER STENT WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; Foreign Body In Patient; Pericardial Effusion; Respiratory Failure

  MAUDE report 24524525 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A PERFORATION OCCURRED THEREFORE TWO 4.0X16MM GRAFTMASTER COVERED STENTS WERE IMPLANTED TO SEAL THE PERFORATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506714 ↗
• InjuryFeb 18, 2026Improper or Incorrect Procedure or Method; Patient-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 24378356 ↗
• InjuryFeb 16, 2026Improper or Incorrect Procedure or Method; Patient-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 24347928 ↗
• 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 ↗

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