Distaflo Bypass GraftsRecalls & reported problems across all models

We found 15 models of Distaflo Bypass Grafts by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jan 11, 2016 and Mar 26, 2026 — classified as 5 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Torn Material” (19 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 Distaflo Bypass Grafts problems

Distaflo Bypass Grafts models

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

• Distaflo® Bypass Grafts DFM8006SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  7 reports
• Distaflo® Bypass Grafts DFX8006SC

  PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
  6 reports
• Distaflo® Bypass Grafts DF7007SC

  PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
  3 reports
• Distaflo® Bypass Grafts DF8007SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  3 reports
• Distaflo® Bypass Grafts DFM6006SC

  PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
  3 reports
• Distaflo® Bypass Grafts DFX7006SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  3 reports
• Distaflo® Bypass Grafts DFX9006SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  3 reports
• Distaflo® Bypass Grafts DF6007SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• Distaflo® Bypass Grafts DF8006SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• Distaflo® Bypass Grafts DF8008SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• Distaflo® Bypass Grafts DF5007SC

  PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
  1 report
• Distaflo® Bypass Grafts DF6006SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• Distaflo® Bypass Grafts DFM5006SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• Distaflo® Bypass Grafts DFM7006SC

  PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
  1 report
• Distaflo® Bypass Grafts DFX6006SC

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report

Recent Distaflo Bypass Grafts adverse event reports

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

• MalfunctionMar 26, 2026Material Split, Cut or Torn

  ON (B)(6) 2026, A PATIENT UNDERWENT A SURGICAL GRAFT IMPLANTATION PROCEDURE BY USING THE DISTAFLO BYPASS GRAFT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GRAFT ALLEGEDLY FRAYED AFTER BEING SEWN IN PLACE AND PRESSURIZED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695497 ↗
• MalfunctionMar 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGICAL GRAFT IMPLANTATION PROCEDURE, WHEN THE GRAFT WAS TRIED TO BE SUTURED, IT ALLEGEDLY GOT TORN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509979 ↗
• MalfunctionAug 7, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A SURGICAL GRAFT IMPLANTATION PROCEDURE, THE GRAFT ALLEGEDLY FELL APART WHILE TRYING TO INSERT INTO THE BODY. IT WAS FURTHER REPORTED THAT RINGS ON THE OUTSIDE OF THE GRAFT STARTED UNCOILING OFF THE GRAFT, THEREFORE THE MIDDLE PIECE OF THE GRAFT WAS EASILY ABLE TO COLLAPSE. THE PROCEDURE WAS COMPLETE USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927346 ↗
• MalfunctionJul 25, 2024Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE IN THE FEMORAL-POPLITEAL ARTERY LESION, THE GRAFT ALLEGEDLY TORE DURING SUTURING OF THE CENTRAL ANASTOMOSIS AND BECAME UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834568 ↗
• MalfunctionMay 6, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, WHEN INSERTING THE PRODUCT, THE EXTERNAL SPIRAL SUPPORT BEADINGS ALLEGEDLY CAME APART. IT WAS FURTHER REPORTED THAT THE BEADINGS ALLEGEDLY POPPED OFF THE GRAFT AND THE GRAFT HAD FLATTENED. REPORTEDLY, THE GRAFT WAS REMOVED WITH BEADINGS STILL ON IT AND THE PROCEDURE WAS COMPLETED BY INSERTING ANOTHER GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246635 ↗
• InjuryAug 2, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THREE MONTHS POST A SURGICAL GRAFT PLACEMENT PROCEDURE, GRAFT MATERIAL ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PSEUDOANEURYSM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pseudoaneurysm

  MAUDE report 17442837 ↗
• InjuryDec 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY TORE ON THE CUFF WHILE SEWING IT UP. REPORTEDLY, THERE WAS PROFUSE BLEEDING FROM THE PUNCTURE CANAL. IT WAS FURTHER REPORTED THAT THE PATIENT WENT TO SURGERY. THE CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12974252 ↗
• MalfunctionDec 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING GRAFT PLACEMENT PROCEDURE, THE GRAFT ALLEGEDLY TORN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10957796 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST GRAFT PLACEMENT, PSEUDOANEURYSM WAS FORMED IN A GRAFT RATHER THAN THE ANASTOMOTIC SITE. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Pseudoaneurysm

  MAUDE report 10903695 ↗
• MalfunctionNov 25, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING SURGICAL GRAFT PLACEMENT PROCEDURE, THE GRAFT ALLEGEDLY TORNED. IT WAS FURTHER REPORTED THAT GRAFT ALLEGEDLY TORE IN SEVERAL PLACES WAS THEN SEWN BACK ON THE TORN AREAS DURING THE SURGERY. REPORTEDLY, THE GRAFT WAS LEFT IN THE PATIENT AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10902406 ↗
• MalfunctionOct 28, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DFM8006SC BYPASS GRAFT ALLEGEDLY EXPERIENCED MATERIAL SPLIT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE WEIGHT OF (B)(6) YEAR OLD MALE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10750348 ↗
• MalfunctionJul 16, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DFM5006SC EPTEE VASCULAR GRAFT ALLEGEDLY MATERIAL SPLIT, CUT OR TORN. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ALLEGED MALFUNCTION HAD PATIENT INVOLVEMENT BUT THERE WERE NO REPORTED PATIENT CONSEQUENCES. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286806 ↗
• InjuryMay 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED APPROXIMATELY ONE WEEK POST FEMORAL TIBIAL GRAFT PLACEMENT, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH GROIN PAIN AND WAS DIAGNOSED WITH PSEUDOANEURYSM DUE TO A RUPTURED GRAFT. THE PATIENT UNDERWENT SURGERY TO REPAIR THE AREA. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Pseudoaneurysm

  MAUDE report 10033057 ↗
• MalfunctionApr 13, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DFM8006SC EPTFE VASCULAR GRAFT ALLEGEDLY EXPERIENCED MATERIAL SPLIT, CUT OR TORN. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954586 ↗
• MalfunctionOct 15, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DFX8006SC DISTAFLO BYPASS GRAFT ALLEGEDLY EXPERIENCED MATERIAL SPLIT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS A (B)(6) MALE WEIGHING (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193018 ↗

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