Strattice Reconstructive Tissue Matrix BPS CON2006Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI M328CON20060), received between Jan 31, 2018 and Apr 29, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE THAT A PATIENT DEVELOPED "AN INFECTION AND "[STRATTICE]" DIDN¿T INCORPORATE." PATIENT "WAS TAKEN BACK" FOR REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 25037973 ↗
• InjuryJan 20, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED VIA THE SALES REPRESENTATIVE THAT THE STRATTICE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT OF CAPSULAR CONTRACTURE, BAKER GRADE III "AS THE PATIENT ALREADY HAD CAP CON BEFORE STRATTICE WAS IMPLANTED." THIS REPORT IS BEING FILED TO UN-REPORT THE EVENT AS IT IS NO LONGER REPORTABLE TO FDA.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123127 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT ENDED UP WITH A PERI PROSTHETIC SEROMA AND HAD TO GO BACK IN FOR SURGERY TO DO A WASHOUT AND IMPLANT EXCHANGE. ADDITIONAL INFORMATION RECEIVED LATER ADVISING THAT AFTER TWO WEEKS OF STRATTICE IMPLANTATION, THE PATIENT HAS EXPERIENCED AN INCREASE IN THE RIGHT BREAST SIZE AND THE ULTRASOUND SHOWED A PERIPROSTHETIC SEROMA. PART OF THE STRATTICE TISSUE WAS EXPLANTED. THE PATIENT IS RECOVERING. THIS RECORD IS TO CAPTURE LOT SP300061-193.

  Patient problems: Seroma

  MAUDE report 23917083 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT ENDED UP WITH A PERI PROSTHETIC SEROMA AND HAD TO GO BACK IN FOR SURGERY TO DO A WASHOUT AND IMPLANT EXCHANGE. THIS RECORD IS TO CAPTURE LOT: SP300061-192.

  Patient problems: Seroma

  MAUDE report 23853889 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE HCP THAT A 45 YEAR OLD FEMALE PATIENT WAS IMPLANTED WITH STRATTICE DEVICE SP200188-155 ON (B)(6) 2020 AND HAS AN INFECTION IN THE LEFT BREAST. THE HCP IS PLANNING ON A DELAYED RECONSTRUCTION TO ALLOW HEALING. EXPLANT SURGERY OCCURRED ON (B)(6) 2023 AND THE DEVICE WAS DISCARDED. NO OTHER INFORMATION WAS REPORTED. THIS RECORD IS ASSOCIATED WITH THE LEFT SIDE/DEVICE 1. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2023-00166 (ABBVIE COMPLAINT # (B)(4)).

  Patient problems: Bacterial Infection

  MAUDE report 17371744 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE HCP THAT A 45 YEAR OLD FEMALE PATIENT WAS IMPLANTED WITH STRATTICE DEVICE (B)(4) ON (B)(6) 2021 AND HAS AN INFECTION IN THE RIGHT BREAST. THE HCP IS PLANNING ON A DELAYED RECONSTRUCTION TO ALLOW HEALING. EXPLANT SURGERY OCCURRED ON (B)(6) 2023 AND THE DEVICE WAS DISCARDED. NO OTHER INFORMATION WAS REPORTED. THIS RECORD IS ASSOCIATED WITH THE RIGHT SIDE/DEVICE 2. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2023-00167 (ABBVIE COMPLAINT # (B)(4).

  Patient problems: Bacterial Infection

  MAUDE report 17371250 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED ON 15/SEP/2022 FROM THE SALES REP ON BEHALF OF THE HCP THAT THEY HAD A PATIENT WHO HAD SURGERY ON (B)(6) 2022 WITH STRATTICE AND SHE ENDED UP HAVING AN IMPLANT EXCHANGE AND HAD HER STRATTICE REMOVED ON (B)(6) 2022 D/T CELLULITIS.THE LOTS ASSOCIATED WITH THIS EVENT WERE REPORTED AS RIGHT BREAST: (B)(4) AND LEFT BREAST: (B)(4). THIS RECORD IS ASSOCIATED WITH RIGHT BREAST: (B)(4). REFER TO MDR 1000306051-2022-00165 FOR THE LEFT BREAST INVESTIGATION.

  Patient problems: Cellulitis

  MAUDE report 15539360 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED ON (B)(6) 2022 FROM THE SALES REP ON BEHALF OF THE HCP THAT THEY HAD A PATIENT WHO HAD SURGERY ON (B)(6) 2022 WITH STRATTICE AND SHE ENDED UP HAVING AN IMPLANT EXCHANGE AND HAD HER STRATTICE REMOVED ON (B)(6) 2022 D/T CELLULITIS. THE LOTS ASSOCIATED WITH THIS EVENT WERE REPORTED AS RIGHT BREAST: (B)(4) AND LEFT BREAST: (B)(4). THIS RECORD IS ASSOCIATED WITH LEFT BREAST: (B)(4). REFER TO MDR 1000306051-2022-00167 FOR THE RIGHT BREAST INVESTIGATION.

  Patient problems: Cellulitis

  MAUDE report 15538678 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS IMPLANTED WITH STRATTICE FOR BREAST AUGMENTATION ON (B)(6) 2020. PATIENT HAD BILATERAL JP DRAINS REMOVED ON (B)(6) 2020 - DRAINS HAD 24-HOUR OUTPUT OF 15-20 CC EACH. PATIENT RETURNED TO THE OFFICE ON (B)(6) 2020 FOR FOLLOW UP WITH COMPLAINTS OF PROGRESSIVE SWELLING IN BILATERAL BREASTS. ¿DR. (B)(6)¿S EXAM SHOWED TENSE, NONTENDER BREAST WITH MILD ERYTHEMA." "PATIENT DEVELOPED HEAVY SEROMA OUTPUT AROUND THE STRATTICE". THE DECISION WAS MADE AT THAT TIME TO RETURN TO THE OPERATING ROOM (OR) TO REMOVE WASHOUT BOTH BREASTS & REMOVE STRATTICE." ¿FLUID WAS EVACUATED IN SURGERY ON (B)(6) 2020, SENT FOR CULTURES, WHICH WERE NEGATIVE". STRATTICE WAS UNINCORPORATED AT THE TIME OF EXPLANT. THE EXPLANTED STRATTICE WERE ALSO SENT FOR CULTURES, THE RESULTS WERE NOT REPORTED. PATIENT SENT TO INFECTIOUS DISEASE & RECEIVED IV ANTIBIOTICS. CEFTRIAXONE 2 G IV Q 24 HOURS & DAPTOMYCIN 320 MG IV Q 24 HOURS ON (B)(6) 2020 FOR 2 WEEKS. IT WAS REPORTED THAT THE SEROMA LEAD TO THE PATIENT HAVING CELLULITIS. PATIENT IS "CURRENTLY OFF OF ANTIBIOTICS AND DOING WELL".

  Patient problems: Cellulitis; Seroma

  MAUDE report 10391133 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT DEVELOPED HEAVY SEROMA OUT PUT AROUND THE STRATTICE, WHICH RESULTED IN THE REMOVAL OF IT. "PATIENT IS DOING WELL."

  Patient problems: Cellulitis; Seroma

  MAUDE report 10251393 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BILATERAL BREAST RECONSTRUCTION WITH STRATTICE ON (B)(6) 2017 POSTOPERATIVELY PRESENTED WITH CAPSULAR CONTRACTURES BILATERALLY. THE LEFT-SIDE CONTRACTURE IS AT BAKER GRADE III AND THE RIGHT-SIDE CONTRACTURE IS AT BAKER GRADE II. THE EXPLANT SURGERY WAS SCHEDULED FOR THE LEFT SIDE ON (B)(6) 2018. THE PATIENT IS NOT HAVING "RIGHT" THE RIGHT-SIDE MESH EXPLANTED. THE STRATTICE LOT NUMBER FOR THE LEFT-SIDE MESH IS SP100493-154. THE STRATTICE LOT NUMBER FOR THE RIGHT-SIDE MESH IS SP100493-107. AS PER CLINICAL FEEDBACK REPORTED BY THE SURGEON ON 15 OCTOBER 2018: THE PATIENT UNDERWENT SUBMUSCULAR IMPLANT EXCHANGE WITH NO COMORBIDITIES. ONSET OF CAPSULAR CONTRACTURE WAS THREE WEEKS POST IMPLANT EXCHANGE WITH PLACEMENT OF STRATTICE BILATERALLY (APPROXIMATELY (B)(6) 2017). THE PATIENT'S COURSE OF TREATMENT INVOLVED ANTIBIOTIC PLACEMENT ON DOXYCYCLINE, SINGULAIR AND VITAMIN E FOR SEVERAL MONTHS. THE SURGEON TOOK THE PATIENT BACK TO THE OPERATING ROOM ON (B)(6) 2018 FOR RIGHT IMPLANT EXCHANGE, COMPLETE CAPSULECTOMY AND REMOVAL OF OLD STRATTICE WITH PLACEMENT OF NEW STRATTICE (JUST THE LEFT STRATTICE MESH WAS REPLACED. THE RIGHT STRATTICE MESH REMAINS

  Patient problems: Capsular Contracture

  MAUDE report 7975158 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT REVISION OF RIGHT BREAST WITH STRATTICE BPS DUE TO CAPSULAR CONTRACTURE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT PRESENTED WITH POST OP INFECTION RESULTING IN SURGICAL AND MEDICAL INTERVENTION THAT DAY. CLOUDY SEROSANGUINEOUS FLUID WAS FOUND AROUND THE IMPLANT AND STRATTICE BPS MESH. THERE WERE NO ABSCESSES OR HEMATOMA. HER IMPLANT WAS INTACT. THE POCKET WAS WASHED OUT, A DRAIN WAS PLACED, THE PATIENT WAS TREATED WITH ANTIBIOTICS, AND THE STRATTICE BPS MESH WAS EXPLANTED ALONG WITH THE IMPLANT. THE PATIENT HAS SINCE RECOVERED AND WAS RESCHEDULED FOR FOLLOW UP PROCEDURE.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 7422467 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR THAT A (B)(6) Y.O. FEMALE PATIENT UNDERWENT BREAST AUGMENTATION AND MASTOPEXY IN 2015. STATUS POST OPERATIVELY, THE PATIENT PRESENTED WITH LEFT CAPSULAR CONTRACTURE. THE PATIENT UNDERWENT LEFT PARTIAL CAPSULECTOMY/CAPSULOTOMY WITH STRATTICE INTERPOSITION, JP DRAIN PLACEMENT, AND RIGHT CAPSULORRHAPHY/CAPSULOTOMY AND BILATERAL MASTOPEXY. A SECOND, UNSPECIFIED PROCEDURE OCCURRED (B)(6) 2017. ON (B)(6) 2017, THE PATIENT UNDERWENT EXPLANTATION OF BILATERAL IMPLANTS AND THE LEFT PLACED STRATTICE, AS THE LEFT SIDE ONLY WAS INFECTED.

  Patient problems: Bacterial Infection

  MAUDE report 7230894 ↗