Strattice Reconstructive Tissue Matrix BPSRecalls & reported problems across all models
Lifecell Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 5 models of Strattice Reconstructive Tissue Matrix BPS by Lifecell Corporation in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2018 and Sep 11, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Strattice Reconstructive Tissue Matrix BPS problems
Device problems
- Adverse Event Without Identified Device or Use Problem32
- Device Appears to Trigger Rejection4
- Lack of Effect2
- Appropriate Device Problem Term/Code Not Available1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture11
- Seroma8
- Bacterial Infection6
- Cellulitis6
- Foreign Body Reaction5
- Hypersensitivity/Allergic reaction5
- No Clinical Signs, Symptoms or Conditions3
- Discharge2
Strattice Reconstructive Tissue Matrix BPS models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Strattice Reconstructive Tissue Matrix BPS CON3006Mesh, Surgical15 reports
- Strattice Reconstructive Tissue Matrix BPS CON2006Mesh, Surgical13 reports
- Strattice Reconstructive Tissue Matrix BPS 0808006Mesh, Surgical5 reports
- Strattice Reconstructive Tissue Matrix BPS CON1006Mesh, Surgical5 reports
- Strattice Reconstructive Tissue Matrix BPS 0416006Mesh, Surgical1 report
Recent Strattice Reconstructive Tissue Matrix BPS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50743222 ↗InjurySep 11, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50742850 ↗InjuryAug 31, 2026Lack of Effect
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50522686 ↗InjuryAug 31, 2026Lack of Effect
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521461 ↗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 ↗InjuryJan 20, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA MEDICAL INFORMATION THAT A PATIENT IMPLANTED WITH BREAST IMPLANTS AND STRATTICE DEVELOPED A SECOND CAPSULAR CONTRACTURE IN BOTH BREASTS AND HIGHER THAN THE LEFT. THIS RECORD REPRESENTS THE RIGHT SIDE STRATTICE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE 3 CAP CON RIGHT BREAST." THIS RECORD REPRESENTS 1 OF 2 STRATTICE DEVICES.
Patient problems: Capsular Contracture
MAUDE report 24122577 ↗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 ↗InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT HAD RIGHT SIDE BREAST IMPLANT WITH STRATTICE IMPLANTED. THE PATIENT THEN SUFFERED "INFECTION AND EXTRUSION" OF THE IMPLANT. ON RE-OPERATION, THE TISSUE WAS NOTED TO BE "PARTIALLY DISSOLVED." THIS RECORD IS FOR THE STRATTICE TISSUE GRAFT. THE RELATED BREAST IMPLANT WAS PREVIOUSLY REPORTED UNDER MRN 9617229-2022-17949 (ABBVIE COMPLAINT NUMBER: (B)(4). PMQA RECEIVED A COMMUNICATION FROM FDA CBER REGARDING RELATED REPORT MRN: 1000306051-2025-00032 (ABBVIE COMPLAINT NUMBER: (B)(4) REPORTING ADDITIONAL INFORMATION PROVIDED BY THE SURGEON ON (B)(6) 2025. THE SURGEON REPORTED PATIENT "HAD REPLACEMENT OF BILATERAL IMPLANTS WITH CAPSULECTOMIES AND STRATTICE SLINGS ON (B)(6) 2025." THE SURGEON PROVIDED LOT NUMBERS WHICH WERE FOR STRATTICE TISSUE. THEREFORE, IT IS ASSUMED THAT THE PATIENT HAD STRATTICE TISSUE IMPLANTED AND NOT ALLODERM.
Patient problems: Bacterial Infection
MAUDE report 22012994 ↗InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FROM THE SALES REP ON BEHALF OF THE HCP THAT A PATIENT HAD STRATTICE LOT, SP200412-125, TO THE PERI PROSTHETIC CAPSULE FOR TREATMENT OF CONTRACTURE AND FOR LOWER POLE SUPPORT ON THE RIGHT SIDE. SHE DID NOT WEAR HER BRA AND BOUNCED HER BREASTS AROUND QUITE A BIT (EXTREMELY LARGE AND FLAT AND LONG) AND HER RIGHT BREAST STRATTICE BECAME DISPLACED UNBEKNOWNST TO THE HCP. SHE DEVELOPED A CONTRACTURE ON THAT SIDE AND WAS NOT RESPONSIVE TO MASSAGE OR ULTRASOUND TREATMENTS. RE-OPERATION WAS UNDERTAKEN AND SHE HAD RED DOTS OF INFLAMMATORY CELLS ALL OVER HER NATIVE CAPSULE (BIOPSY SHOWED GIANT CELL REACTION WITH EOSINOPHILS) AND A SMALL AMOUNT OF CLEAR FLUID AND A POCKET OF STERILE PURULENT MATERIAL IN THE AREA OF THE DISPLACED AND CRUMPLED STRATTICE. THE HCP DEBRIDED THE UNINCORPORATED STRATTICE, CLEANED OUT ALL DEBRIS AND INJECTED THE CAPSULE WITH KENALOG WHERE THEY WOULD NOT INTERFERE WITH THE PATIENT'S EXTREMELY THIN SOFT TISSUE IMPLANT COVERAGE (ESSENTIALLY SKIN ON IMPLANT) AND PUT THE IMPLANT BACK IN. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 AND DID FINE FOR SEVERAL WEEKS AND AS AN AFTER THOUGHT, WAS PUT ON STEROIDS POST OPERATIVELY. THE PATIENT WAS SEEN (B)(6) AND
Patient problems: Capsular Contracture; Seroma
MAUDE report 17454656 ↗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 ↗InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FROM THE SALES REP ON BEHALF OF THE CUSTOMER THAT A PATIENT PREVIOUSLY IMPLANTED WITH STRATTICE WHO HAD A COMPLAINT OF CAPSULAR CONTRACTURE ON THE RIGHT BREAST, NOW DEVELOPED GRADE 4 CAPSULAR CONTRACTURE ON THE LEFT BREAST. THE HCP IS PLANNING TO REMOVE AND IMPLANT 2 NEW PIECES ON HER LEFT SIDE IN JULY. THE PATIENT ALSO HAS MENTOR SILICONE GEL IMPLANTS. THE PREVIOUS COMPLAINT FOR THE RIGHT BREAST IS DOCUMENTED UNDER (B)(4) MDR# 1000306051-2023-00020. THIS RECORD IS ASSOCIATED WITH HER LEFT BREAST, LOT SP200344-150.
Patient problems: Capsular Contracture
MAUDE report 17201163 ↗InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FROM THE SALES REP ON BEHALF OF THE HCP THAT THEY HAVE A PATIENT WHO DEVELOPED CAPSULAR CONTRACTURE WITH STRATTICE LOT: SP200354-085 IMPLANTED ON (B)(6) 2022. THEY ARE REMOVING AND IMPLANTING A NEW PIECE. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 18/JAN/2023 THAT THE PATIENT UNDERWENT BREAST AUGMENTATION WITH PLACEMENT OF SILICONE GEL IMPLANTS. THERE WAS FIRMNESS ON RIGHT BREAST NOTED ON 5 MONTHS LATER, 7 MONTHS GRADE 4 CAPSULAR CONTRACTURE NOTED. TREATMENT INCLUDED RIGHT BREAST REMOVAL AND REPLACEMENT OF SILICONE GEL IMPLANT, 2 PIECES OF ADM. IT WAS NOTED THE PATIENT HAS A PREVIOUS HISTORY OF CAPSULAR CONTRACTURE.
Patient problems: Capsular Contracture
MAUDE report 16268910 ↗
Other Lifecell Corporation products
All Lifecell Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page