Natrelle 133S Tissue Expanders 133S-MV-16-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10888628043909), received between Jun 21, 2019 and Sep 29, 2026 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Detachment of Device or Device Component

  Sales representative reported "Expander came apart inside the patient". This record is for an unknown side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935111 ↗
• InjuryNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED THROUGH SALES REPRESENTATIVE "RUPTURED". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23534435 ↗
• MalfunctionFeb 15, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  COMPANY REPRESENTATIVE REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL "ISSUE WITH THE NATRELLE PACKAGING. HAVING DIFFICULTY REMOVING THE INNER PACKAGING FROM THE OUTER BOX. IT¿S VERY DIFFICULT TO REMOVE THE PRODUCT, AND MAY LEAD TO PROBLEMS WITH TRANSFERRING THE IMPLANTS/TES INTO THE STERILE FIELD". DEVICE STATUS UNKNOWN. UNKNOWN IF PATIENT CONTACT OCCURRED.

  Patient problems: Failure of Implant

  MAUDE report 18716636 ↗
• InjuryJul 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "THERE WAS A BREACH ANTERIORLY RIGHT WHERE THE PORT PLATE MEETS THE IMPLANT." THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17278318 ↗
• InjuryJun 14, 2022Break; Break

  HEALTHCARE PROVIDER REPORTED UNKNOWN SIDE ONE OF ¿ALLERGAN¿S TISSUE EXPANDERS HAD A HOLE IN IT. IF I GOT THE STORY CORRECT IT WAS IMPLANTED BEFORE THEY DISCOVERED THE PROBLEM¿. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14689890 ↗
• InjuryNov 30, 2021Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 12895001 ↗
• InjuryJul 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "FOLDED OVER ON ITSELF" AND "DEFLATION." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12221037 ↗
• InjuryJul 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A DEFLATION WITH A TISSUE EXPANDER FOR AN UNKNOWN SIDE. THE PHYSICIAN USED TISSUE EXPANDER BEYOND THE RECOMMENDED EXPANSION PERIOD. IT IS UNKNOWN IF THE EXPANSION WAS COMPLETED. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12132098 ↗
• InjuryMar 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11473903 ↗
• InjuryFeb 19, 2021Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "SLOW LEAK." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11347597 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFECTION (EARLY ONSET). THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 11165658 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE INFECTION (EARLY ONSET). THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 11165426 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "INFECTION". DEVICE REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 11023761 ↗
• InjuryOct 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY THAT THE "PATIENT REPORTED DEFLATION OF THE RIGHT SIDE TISSUE EXPANDER AND INCREASED OUTPUT FROM THE DRAIN WHICH APPEARED CLEAR IN COLOR." AFFECTED SIDE IS RIGHT. THE DEVICE HAS BEEN EXPLANTED. PATIENT WAS REPLACED WITH ANOTHER TISSUE EXPANDER.

  Patient problems: Failure of Implant

  MAUDE report 10766829 ↗
• MalfunctionJun 21, 2019Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  COMPANY REPRESENTATIVE REPORTED ON BEHALF OF THE PHYSICIAN THAT WHEN THE PHYSICIAN "ATTEMPTED TO BEGIN FILLING THE TISSUE EXPANDER WITH THE FOURTE NEEDLE AND OUR MAGNA FINDER. AFTER MARKING THE MAGNESITE HE INSERTED FOURTE INTO THE SKIN. AT THAT POINT THE FOURTE MISSED THE MAGNESITE AND PUNCTURED THE TISSUE EXPANDER."DOCTOR FEELS THIS WAS DUE TO A SMALL INJECTION PORT/AND A BLUNTING OF FOURTE NEEDLES WHICH MADE SKIN DIFFICULT TO PENETRATE, SKIN WAS MOVING." THE DEVICE HAD TO BE REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723454 ↗