Natrelle 133S Tissue Expanders 133S-FV-14-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888628043800), received between Feb 14, 2020 and Dec 17, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TISSUE EXPANDER TORE RIGHT BELOW THE MAGNET AS WELL AS LOST A TAB". THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23833034 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE 6¿OCLOCK TAB WAS STARTING TO TEAR AWAY FROM THE EXPANDER BUT NOT TOTALLY DETACHED, "PERSISTENT CELLULITIS, AND NECROSIS." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Cellulitis; Necrosis

  MAUDE report 22862710 ↗
• InjuryOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE DEFLATION. THE TISSUE EXPANDER HAD BEEN IMPLANTED FOR LONGER THAN 6 MONTHS. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17905117 ↗
• InjuryJul 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER TISSUE EXPANDER.

  Patient problems: Failure of Implant

  MAUDE report 17383828 ↗
• InjuryJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  COMPANY REPRESENTATIVE REPORTED LEFT SIDE DEFLATION OF A TISSUE EXPANDER. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17301759 ↗
• InjuryNov 17, 2022Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE" OF SALINE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 15815248 ↗
• InjuryOct 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  HEALTH PROFESSIONAL REPORTED LEFT SIDE ¿THE TISSUE EXPANDER HAD A SEEM RUPTURE¿ OF A SALINE DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15592191 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CELLULITIS WITH PERSISTENT DRAINAGE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Cellulitis; Fluid Discharge

  MAUDE report 14323219 ↗
• MalfunctionMay 7, 2022Break; Break

  HEALTHCARE PROFESSIONAL REPORTED A DEVICE WAS NOT IMPLANTED DUE TO "HAD A CREASE THAT WOULD NOT POP OUT WHEN FILLED¿ AND ¿AFTER MANIPULATED MANUALLY IT POPPED OUT¿, ¿SURGEON WAS WORRIED THAT AREA MIGHT BE A WEAK SPOT SO WANTED IT RETURNED¿. DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322455 ↗
• InjurySep 18, 2020Break; Break

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFECTIVE TISSUE EXPANDER, WHEN FILLING THE EXPANDER, THERE WAS A DENT IN THE MIDDLE AND THE EXPANDER WOULD NOT FULLY INFLATE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10553936 ↗
• InjuryFeb 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "REMOVED AN IMPLANT SIZER FROM PATIENT ONE MONTH AFTER IMPLANTATION DUE TO A STRESS FRACTURE...DAMAGED DEVICE". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9731981 ↗
• InjuryFeb 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9710710 ↗