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

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10888628043886), received between May 31, 2019 and Sep 30, 2026 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "Infection" and "Seroma". This record is for the left side. Device was explanted.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 50945682 ↗
• InjuryApr 10, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "SPONTANEOUS RUPTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845123 ↗
• InjuryApr 9, 2026Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "HAD SPONTANEOUS RUPTURE". LATER, PATIENT REPORTED "RUPTURED", "500 EXPANDER EXPANDED TO 570". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24827461 ↗
• InjuryApr 17, 2025Fluid/Blood Leak; Device Handling Problem; Fluid/Blood Leak; Device Handling Problem

  PATIENT REPORTED LEFT SIDE "MULTIPLE INFECTIONS FROM THE EXPANDER", "FLUID IN CHEST", "LYMPHEDEMA", AND "THE SURGEON PUT AIR IN THE EXPANDER". PATIENT ALSO REPORTED THEY "NOTICED SWOLLEN LYMPH NODES" AND HAD A PROCEDURE TO "PULL OUT THE FLUID [FROM THEIR CHEST]". PATIENT ALSO REPORTED THE FOLLOWING EVENTS, WHICH ARE NOT DEVICE-RELATED: "SHINGLES", "PULMONARY NODES FROM RADIATION THERAPY", ¿PLEURAL EFFUSION¿, AND ¿DIFFICULTY IN MOVING LEFT HAND¿. DEVICE HAS BEEN EXPLANTED. PATIENT WAS TREATED WITH ANTIBIOTICS PRIOR TO EXPLANT.

  Patient problems: Seroma; Swelling/ Edema; Swollen Lymph Nodes/Glands; Unspecified Infection

  MAUDE report 21853268 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "INFECTED AND CAUSED SIRS" AND "CAUSED INJURY; MUCH DISCOMFORT, PAIN, A VISUALLY DEFORMED BREAST, AND EMBARRASSMENT IN APPEARANCE, ABILITY TO WORK AND PERFORM DAILY ACTIVITIES". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20669104 ↗
• InjurySep 29, 2023Fluid/Blood Leak; Device Handling Problem; Fluid/Blood Leak; Device Handling Problem

  COMPANY REPRESENTATIVE ON BEHALF OF HEALTHCARE PROFESSIONAL REPORTED "LEAKING" FOR AN UNKNOWN SIDE. COMPANY REPRESENTATIVE LATER REPORTED "HE NOTED THAT IT WAS PUNCTURED FROM HIS SUTURE WHEN HE IMPLANTED IT" AND "HE KNEW IT WAS HIS ERROR AND MISTAKE THAT PUNCTURED IT". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17848490 ↗
• InjurySep 14, 2023Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED TISSUE EXPANDER HAS RUPTURED. THIS IS FOR AN UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17744349 ↗
• MalfunctionJun 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED AN UNKNOWN SIDE RUPTURE OF A SALINE TISSUE EXPANDER. DEVICE WAS REPLACED WITH A BREAST IMPLANT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17066459 ↗
• InjuryMar 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  COMPANY REPRESENTATIVE REPORTED "A SPLIT AT THE SEAM OF THE TE (TISSUE EXPANDER)" AND USE ERROR AGAINST AN UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16513132 ↗
• InjuryJan 31, 2023Deflation Problem; Deflation Problem

  HEALTHCARE PROFESSIONAL REPORTED DEFLATION. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16272714 ↗
• InjuryAug 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15307223 ↗
• InjuryAug 19, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  COMPANY REPRESENTATIVE REPORTED "WHITE MARKS" AGAINST DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15258019 ↗
• InjuryJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Failure of Implant

  MAUDE report 15112305 ↗
• InjuryApr 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "THE SEAM AROUND THE DIFFERING PLASTIC PARTS OF THE EXPANDER HAD WHAT APPEARED TO BE A HOLE IN IT. THE FLUID SQUIRTED OUT OF THIS HOLE WHEN THE EXPANDER WAS SQUEEZED¿. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14109036 ↗
• InjuryMar 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  PHYSICIAN REPORTED RIGHT "SPONTANEOUS DEFLATION OF TISSUE EXPANDER". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13809210 ↗
• InjuryFeb 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "RIGHT SIDE REMOVAL IS NOTED AS ¿INFECTION.¿ DEVICE EXPLANTED. RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 13595668 ↗
• InjuryAug 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE" OF A TISSUE EXPANDER AND THAT THE DEVICE WAS "MALPOSITIONED, ROLLED, AND POSTERIOR TAB WAS JUST UNDER CAPSULE." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12365930 ↗
• MalfunctionApr 9, 2021Break; Break

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "DISCOVERED IT HAD A HOLE." DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11644620 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "HAD SUPERFICIAL SEROMAS THAT DRAINED SPONTANEOUSLY. A PHYSICIAN ALLOWED DRAINAGE AT THE POINT PATIENT HAD CELLULITIS ON BOTH BREASTS".THE "SURGICAL WOUND BREAKDOWN" AS POSTOPERATIVE OBSERVATION. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Cellulitis; Seroma; Wound Dehiscence

  MAUDE report 11289870 ↗
• InjuryFeb 4, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "HAD SUPERFICIAL SEROMAS THAT DRAINED SPONTANEOUSLY. A PHYSICIAN ALLOWED DRAINAGE AT THE POINT PATIENT HAD CELLULITIS ON BOTH BREASTS." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "BIOFILM," "SURGICAL WOUND BREAKDOWN, EXPOSURE, AND MURKY FLUID DRAINING FROM SITE." TREATMENT HAD BEEN PROVIDED IN THE FORM OF "LEVOQUIN, IV CLINDAMYCIN, AND I&D." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Cellulitis; Seroma; Wound Dehiscence

  MAUDE report 11282069 ↗
• InjuryDec 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PARTIAL DEFLATION OF EXPANDER, REQUIRED MULTIPLE REPEAT FILLS, BUT THE POCKET WAS COLLAPSED DUE TO DEFLATED DEVICE". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10982587 ↗
• InjurySep 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE LEAKING TISSUE EXPANDER. IT WAS UNKNOWN IF THE DEVICE IS BEING EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10578951 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS SALES REP REPORTED THE FOLLOWING ON BEHALF OF HCP FOLLOWING EXPANDER PLACEMENT "MASTECTOMY FLAP BEGAN TO NECROSIS, AND SUTURE TABS (3 TOTAL) HAD PULLED AWAY FROM THE EXPANDER." ADDITIONALLY REP REPORTED "SUTURES DID NOT PULL THROUGH THE TABS RATHER THE WHOLE TAB PULLED AWAY FROM EXPANDER." DEVICE HAS BEEN EXPLANTED. UNKNOWN SIDE.

  Patient problems: Necrosis

  MAUDE report 10359101 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED VIA REGULATORY AGENCY RIGHT SIDE "SWOLLEN AND RED," AND "PSEUDOMONAS" INFECTION AND "AUTO-IMMUNE TRIGGER SINCE THE PLACEMENT" OF A TISSUE EXPANDER. TREATMENT WITH ANTIBIOTICS AND SURGICAL INTERVENTION OF "INCISION REMOVED AND SUTURED BACK." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9734687 ↗
• InjuryFeb 20, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT REPORTED VIA REGULATORY AGENCY "LEFT BREAST BECAME TENDER WITH REDNESS AND SWELLING," "DRAIN," "PSEUDOMONAS," "THICK YELLOW DRAINAGE," "PIN SIZE HOLE IN INCISION LINE OPENED UP," "PENCIL ERASER SIZE HOLE IN SKIN," "HOLE SIZE OF A DIME," "LEFT INCISION LINE DEVELOPED AN AREA OF BLACK TISSUE," "BLACK TISSUE FALLS OFF" AND "AUTO-IMMUNE TRIGGER SINCE THE PLACEMENT" OF A TISSUE EXPANDER. TREATMENT WITH ANTIBIOTICS AND SURGICAL INTERVENTION OF "WASH LEFT BREAST AND EXPANDER" OCCURRED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Necrosis; Unspecified Infection; Wound Dehiscence

  MAUDE report 9732176 ↗