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Strattice Reconstructive Tissue Matrix BPS 0416006Recalls & reported problems

Lifecell Corporation · BPS Strattice 4 cm x 16 cm - Pliable · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M32804160060), received between Apr 25, 2019 and Apr 25, 2019 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Seroma1

Recent adverse event reports

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

  • InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH STRATTICE BPS (LOT NUMBER: SP100528) ON (B)(6) 2017. IN THE MONTHS FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED FLUID ACCUMULATION SURROUNDING THE BREAST ALTERNATING FROM ONE SIDE TO THE OTHER. THE SURGEON ADVISED THEY BELIEVED THE FLUID WAS AN ¿INFLAMMATORY RESPONSE DUE TO THE TISSUE NEVER INTEGRATING INTO THE SKIN.¿ ON (B)(6) 2019 THE PATIENT HAD THE STRATTICE EXPLANTED. THE PRODUCT HAS NOW BEEN DISCARDED AND IS NOT AVAILABLE FOR RETURN.

    Patient problems: Seroma

    MAUDE report 8549304 ↗

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