GalaFLEX 3D 100042-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810054980261), received between Mar 20, 2023 and Aug 27, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K161092); they may or may not involve this specific model.

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2024 - Patient had history of breast augmentation, breast ptosis stage 1, double bubble deformity bilateral thereby underwent repair with the placement of two GalaFlex 3D Scaffold (Device 1 - Right & Device 2 - Left). Per op notes, "Attention to the breast with epinephrine was placed below at the prior IMF incision and was carried down to the breast pocket. The implants were removed. Two GalaFlex 3D Scaffold (Device 1 - Right & Device 2 - Left) were sutured down to the IMF fascia. The implants were placed back into the pocket and the subcutaneous tissue. The superior and lateral glandular tissue was then incised, and the nipple areolar complex was mobilized upward to the mid portion of the implant."This file represents GalaFlex 3D (Device 2 - Left).

  Patient problems: Pain

  MAUDE report 50472623 ↗
• InjuryMay 15, 2026Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BREAST AUGMENTATION SURGERY ON (B)(6) 2024, DURING WHICH A GALAFLEX MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IMPLANTATION SITE, WHICH LED TO A SUBSEQUENT SURGICAL INTERVENTION. ON (B)(6) 2025, THE GALAFLEX MESH WAS SURGICALLY EXCISED DUE TO THE REPORTED PAIN. DESPITE THE REMOVAL, THE PATIENT CONTINUED TO EXPERIENCE COMPLICATIONS AND THEREFORE UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2025. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL SURGICAL INTERVENTION, MENTAL ANGUISH AND CHRONIC PAIN. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Pain

  MAUDE report 25191207 ↗
• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, WHEN RECEIVED THE GALAFLEX 3DR MESH BOX WAS FOUND TO BE DAMAGED AND THE INTERNAL WRAPPER OF THE MESH PACKAGING WAS ALSO BREACHED WHICH COMPROMISED THE STERILITY. THE MESH WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ADDENDUM: IT WAS REPORTED, THE BOX WAS DAMAGED WITH A CUT IN THE BOX AND THE INNER STERILE PACKAGING WAS ALSO DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413201 ↗
• MalfunctionMar 20, 2023Material Deformation; Material Deformation

  AS REPORTED, PATIENT UNDERWENT BREAST AUGMENTATION REVISION SURGERY ON (B)(6) 2022 WITH THE IMPLANT OF GALAFLEX 3D SCAFFOLD. AS REPORTED 8 MONTHS POST IMPLANT, PATIENT HAD INFERIOR MARGIN RIGHT BREAST RETRACTED. IT WAS REPORTED DURING EXAM, PALPATION REVEALED A FIRM RIDGE WHICH IS "ASSUMED TO BE ROLLED GALATEA MESH." NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN REPORTED. PATIENT IS SCHEDULED TO FOLLOW UP WITH SURGEON, WILL BE ADVISED OF THE ABSORPTION RATE AND FURTHER TREATMENT WILL BE PLANNED.

  Patient problems: Physical Asymmetry

  MAUDE report 16577446 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161092. One submission often covers many models, so check the product and lot details in each record.

• Z-0948-2017 · Nov 21, 2016 · Terminated
  GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce de