taperflo™ W40T0406SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881009599), received between Mar 22, 2018 and Aug 22, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2018Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem

  THE EVENT WAS REPORTED TO VASCUTEK ON (B)(6) 2018 AS FOLLOWS: "BLOOD LEAKAGE: ON (B)(6) 2018: THE TAPERFLO WAS IMPLANTED AT THE (B)(6) HOSPITAL. AFTER THE SHUNT WAS MONITORED FOR ABOUT THREE WEEKS AT THE HOSPITAL, THE PATIENT WAS TRANSFERRED TO A DIALYSIS FACILITY AND CONTINUED THE DIALYSIS TREATMENT. ON (B)(6) 2018: A HEMATOMA WAS OBSERVED DUE TO BLOOD LEAKAGE FROM THE LOOP PORTION OF THE TAPERFLO. THE PATIENT WAS TRANSFERRED TO THE (B)(6) HOSPITAL AND THE TAPERFLO WAS REMOVED FROM THE PATIENT. THE PATIENT IS CURRENTLY BEING MONITORED AND THE CONDITION IS STABLE AFTER THE PROCEDURE. OPERATION TYPE: FEMORAL ARTERY ARTIFICIAL BLOOD VESSEL REPLACEMENT SURGERY." FURTHER INFORMATION: "SINCE THE PATIENT WAS RECEIVING DIALYSIS WITHOUT PROBLEMS AFTER IMPLANTING THE TAPERFLO, THE HOSPITAL CONFIRMED THAT THE DIALYSIS FACILITY DID NOT PUNCTURE THE LOOP PORTION. HOWEVER, THE HOSPITAL WOULD LIKE TO KNOW THE CONDITION ON THE LOOP, SUCH AS PUNCTURE MARKS ON THE LOOP." IT WAS REPORTED THAT THERE WAS NO IMPACT ON PATIENT HEALTH AND EVENT WAS POSSIBLY RELATED TO DEVICE.

  Patient problems: Hematoma

  MAUDE report 7804183 ↗
• MalfunctionMar 22, 2018Occlusion Within Device; Material Puncture/Hole; Occlusion Within Device; Material Puncture/Hole

  TERUMO (B)(4) REPORTED GRAFT OCCLUSION: THE 10TH DAY AFTER IMPLANT, PUNCTURING WAS PERFORMED SINCE THE CONDITION OF THE PATIENT LOOKED GOOD WITH NO SWELLING. THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL AND SENT BACK TO THE CLINIC IN WHICH THE PATIENT HAD BEEN HOSPITALIZED ORIGINALLY. THE 37TH DAY AFTER IMPLANT, THE PATIENT WAS SENT BACK TO THE HOSPITAL AGAIN BECAUSE THE GRAFT WAS OCCLUDED. WHEN THE GRAFT WAS EXPLANTED, THE FOLLOWING WERE FOUND: JELLY-LIKE SUBSTANCES SURROUNDING THE GRAFT DID NOT ADHERE TO THE GRAFT. THE GRAFT WAS FLAT, AND WHEN THE GRAFT WAS PUNCTURED WITH A NEEDLE, THE NEEDLE PERFORATED THE FRONT AND REAR WALLS OF THE GRAFT. A LOW-ECHOIC AREA OF SEROMA-LIKE SUBSTANCES WAS OBSERVED AROUND THE ENTIRE LENGTH OF THE GRAFT WHICH WAS CRUSHED FLATLY. WHEN THE GRAFT WAS REPLACED WITH A THORATEC GRAFT, THE IMPLANTED GRAFT WAS EASILY REMOVED WITHOUT ADHERING TO THE TISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361901 ↗