GalaFLEX 3D 100042-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810054980315), received between Jun 10, 2022 and Jul 31, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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.

• InjuryJul 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A BREAST IMPLANT EXCHANGE ON (B)(6) 2025. ABOUT 5 WEEKS POSTOP, THE PATIENT PRESENTED IN WITH AN UNSPECIFIED INFECTION VERY LATE IN THE HEALING PROCESS ON THE RIGHT BREAST. ON (B)(6) 2025, PATIENT UNDERWENT REMOVAL OF THE MESH AS IT WAS POTENTIAL AFFECTED BY THE INFECTION AND WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 22676247 ↗
• InjuryMar 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED, PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION WITH IMPLANT OF GALAFLEX 3D MESH ON (B)(6) 2025. AT THE 4 WEEK FOLLOW UP APPOINTMENT THE PATIENT PRESENTED WITH EXPOSED IMPLANT ON THE RIGHT BREAST POST IMPLANT. IT WAS REPORTED THAT IT DID NOT HEAL, AND NO ISSUE WAS FOUND ON THE LEFT BREAST POST IMPLANT. SURGEON PLANNED TO REMOVE THE IMPLANT ON (B)(6) 2025 AND TO REPLACE WITH NEW IMPLANT ONCE THE HEALED. NO FURTHER INFORMATION HAS BEEN PROVIDED ON WHETHER THE IMPLANT WAS REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 21644280 ↗
• InjuryNov 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2024 PATIENT UNDERWENT A BILATERAL BREAST AUGMENTATION WITH GALAFLEX 3D MESH IMPLANTED. IT WAS REPORTED THAT POST IMPLANT, PATIENT WAS PRESENTED WITH SYMPTOMS (FEVER AND POCKETING) OF REJECTING EITHER THE IMPLANTS OR THE GALAFLEX 3D THEREBY UNDERWENT REMOVAL OF GALAFLEX 3D MESH ON (B)(6) 2024. AS REPORTED, THE PATIENT WAS PRESCRIBED ANTIBIOTICS POST OP.

  Patient problems: Bacterial Infection; Foreign Body Reaction

  MAUDE report 20640623 ↗
• InjuryJun 10, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-(B)(4): ON (B)(6) 2016, PATIENT UNDERWENT BILATERAL REVISION MASTOPEXY WITH AUTO-AUGMENTATION USING AN 'OTHER' INCISION : AREOLA, WISE PATTERN SUPERIOR PEDICLE. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES WERE LIPOSUCTION, MASTOPEXY, AUTO-AUGMENTATION. ON (B)(6) 2016, BILATERAL BREAST SEROMA WAS REPORTED. SAE. PATIENT HAD PROCEDURES OF ASPIRATION OF SEROMA BEGINNING (B)(6) 2016. SEROSANGUINOUS DRAINAGE EVACUATED FROM BOTH BREASTS ON SEVERAL DATES. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED SEROMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Seroma

  MAUDE report 14654250 ↗

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