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VersaWrap VTP-2201Recalls & reported problems

Alafair Biosciences, Inc. · VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch. · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B454VTP22010), received between Sep 29, 2023 and Sep 29, 2023 — classified as 2 injuries.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Abscess2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2023, USING A DA VINCI SYSTEM, A PERITONECTOMY WAS PERFORMED. VERSAWRAP WAS APPLIED TO THE RAW SURFACES WHERE THE PERITONEUM WAS REMOVED. AMNIOFIX (MIMEDX) WAS ALSO USED IN THE PROCEDURE. TWO (2) WEEKS POSTOPERATIVE THE PATIENT PRESENTED WITH PAIN. MRI IDENTIFIED A 30 CM ABSCESS IN THE LOWER LEFT PELVIS. CULTURE WAS NEGATIVE. THE PATIENT WAS DRAINED, REQUIRING A ONE-WEEK STAY IN THE HOSPITAL. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND PRESCRIBED A 6 WEEK TREATMENT OF ANTIBIOTICS. A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DEVICE IS PROVIDED TO THE END USER AS A STERILE DEVICE. THE DEVICE WOULD NOT CAUSE AN INFECTION. ALAFAIR BIOSCIENCES HAS A VALIDATED STERILIZATION CYCLE WITH A STERILITY ASSURANCE LEVEL OF (SAL) 10^-6. THE VALIDATED STERILITY CYCLE AND ALL PARAMETERS OF ALL DEVICES ARE VERIFIED PRIOR TO RELEASE FOR DISTRIBUTION. THE ROOT CAUSE OF THE PRESENCE OF A PELVIC ABSCESS IS INCONCLUSIVE. IN A SUBSEQUENT CONVERSATION WITH THE SURGEON, THE SURGEON INDICATED THAT THE PATIENT IS DOING WELL AND IMPROVING; AS OF (B)(6) 2023 THE PATIENT HAS ONE WEEK REMAINING OF A 6-WEEK COURSE OF ANTIBIOTICS.

    Patient problems: Abscess

    MAUDE report 17845527 ↗
  • InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2023, USING A DA VINCI SYSTEM, A PERITONECTOMY WAS PERFORMED. VERSAWRAP WAS APPLIED TO THE RAW SURFACES WHERE THE PERITONEUM WAS REMOVED. AMNIOFIX (MIMEDX) WAS ALSO USED IN THE PROCEDURE. TWO (2) WEEKS POSTOPERATIVE THE PATIENT PRESENTED WITH FEVER AND PAIN. MRI IDENTIFIED FLUID NEAR THE FALLOPIAN TUBE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DEVICE IS PROVIDED TO THE END USER AS A STERILE DEVICE. THE DEVICE WOULD NOT CAUSE AN INFECTION. ALAFAIR BIOSCIENCES HAS A VALIDATED STERILIZATION CYCLE WITH A STERILITY ASSURANCE LEVEL OF (SAL) 10^-6. THE VALIDATED STERILITY CYCLE AND ALL PARAMETERS OF ALL DEVICES ARE VERIFIED PRIOR TO RELEASE FOR DISTRIBUTION. THE ROOT CAUSE OF THE PRESENCE OF A PELVIC ABSCESS IS INCONCLUSIVE. IN A SUBSEQUENT CONVERSATIONS WITH THE SURGEON, THE SURGEON INDICATED THAT THE PATIENT RECOVERED AND IS DOING WELL.

    Patient problems: Abscess

    MAUDE report 17845456 ↗

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Sources and updates

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