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SealPTFE™ S2005SRecalls & reported problems

Vascutek Ltd · SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881002736), received between Sep 27, 2018 and Sep 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Degraded1
  • Material Integrity Problem1
  • Peeled/Delaminated1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 27, 2018Degraded; Peeled/Delaminated; Material Integrity Problem; Degraded; Peeled/Delaminated; Material Integrity Problem

    THE EVENT WAS REPORTED TO VASCUTEK ON (B)(6) 2018 AS FOLLOWS: "GELATIN WAS SEPARATED. THE GRAFT WAS SUTURED TO A BLOOD VESSEL AS A SHUNT. AFTER ONE SIDE OF THE GRAFT WAS SUTURED TO THE BLOOD VESSEL ACCORDING TO THE IFU, WHEN THE OTHER SIDE WAS CUT OFF TO BE IMPLANTED ITS GELATIN WAS SEPARATED( SCATTERED). THE GRAFT WAS REMOVED FROM THE PATIENT AND REPLACED WITH TWO SEALPTFE GRAFTS CAT NO. S2005S. THE REPLACEMENT GRAFTS WERE IMPLANTED WITHOUT ANY ISSUE." SITE HAS REPORTED NO HEALTH ISSUE FOR PATIENT.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 7913462 ↗

Other GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE devices

All GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.