Natrelle 133S Tissue Expanders 133S-FV-13-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888628043794), received between Oct 19, 2020 and Jun 6, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED ¿HAD AN OPEN WOUND", "MY BODY REJECTED THE IMPLANT", AND "MY BODY WENT SCEPTIC¿. LATER PATIENT PRESENTED OPERATIVE NOTES REPORTING "DELAYED WOUND CLOSURE", "SOFT TISSUE INFECTION", AND "COPIOUS AMOUNT OF INFECTED SEROMA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Seroma; Unspecified Infection; Wound Dehiscence

  MAUDE report 25419580 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REPRESENTATIVE REPORTED ¿SEVERAL WEEKS AFTER PLACEMENT INFECTION DEVELOPED.¿ DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23059644 ↗
• InjuryMay 23, 2023Break; Break

  PHYSICIAN REPORTED UNKNOWN SIDE TISSUE EXPANDER WITH A HOLE. DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984633 ↗
• InjuryMay 17, 2023Device-Device Incompatibility

  (B)(6) 2022, I RECEIVED DOUBLE MASTECTOMY SURGERY FOR LEFT DUCTUS CARCINOMA. THE PLASTIC SURGEON DID NOT COMMUNICATE PREVIOUS APPOINTMENTS, SURGERY INFORMED CONSENT DID NOT STATE THE INFORMATION THAT I SHOULD NO LONGER HAVE MRIS OR POST-SURGERY APPOINTMENTS THAT I COULD NOT HAVE AN MRI WITH THE TISSUE EXPANDERS CONTAINING A MAGNETIC/METAL PORT THAT THEY USE TO HELP LOCATE THE PORT TO PUT IN IV FLUID POST-SURGERY AND EXPAND THE TISSUE. (B)(6) 2022, I HAD THE RIGHT BREAST TISSUE EXPANDER PLACED AND NOT ON THE LEFT. NEXT SURGERY FOR THE LEFT TISSUE EXPANDER SURGERY (B)(6) 2022 - NO INFORMATION WAS PROVIDED ON ANY PLASTIC SURGERY APPOINTMENTS PRIOR TO THIS SURGERY, ON INFORMED CONSENT SURGERY FORM OR POST-SURGERY REGARDING THE RESTRICTION OF NOT HAVING AN MRI COMPLETED. ASKED BY RN TO SIGN A BLANK INFORMED CONSENT. I HAD MULTIPLE SCLEROSIS (MS) PRIOR TO CANCER AND STATED AT MY PRE-SURGERY APPOINTMENTS THAT I HAD MY MS MEDICATION HALTED WITH THE POTENTIAL OF CANCER SECONDARILY TO THIS (LATER NOTED NOT RELATED TO HER2+ CANCER DIAGNOSIS). WHEN I AM NOT TAKING ANY MS MEDICATIONS, MY NEUROLOGIST PREFERS TO HAVE A BRAIN MRI COMPLETED EVERY 6 MONTHS TO MONITOR ANY PROGRESSION IN POTENTIAL BRA

  Patient problems: Insufficient Information

  MAUDE report 16952658 ↗
• InjuryMay 17, 2023Device-Device Incompatibility

  (B)(6) 2022, I RECEIVED DOUBLE MASTECTOMY SURGERY FOR LEFT DUCTUS CARCINOMA. THE PLASTIC SURGEON DID NOT COMMUNICATE PREVIOUS APPOINTMENTS, SURGERY INFORMED CONSENT DID NOT STATE THE INFORMATION THAT I SHOULD NO LONGER HAVE MRIS OR POST-SURGERY APPOINTMENTS THAT I COULD NOT HAVE AN MRI WITH THE TISSUE EXPANDERS CONTAINING A MAGNETIC/METAL PORT THAT THEY USE TO HELP LOCATE THE PORT TO PUT IN IV FLUID POST-SURGERY AND EXPAND THE TISSUE. (B)(6) 2022, I HAD THE RIGHT BREAST TISSUE EXPANDER PLACED AND NOT ON THE LEFT. NEXT SURGERY FOR THE LEFT TISSUE EXPANDER SURGERY (B)(6) 2022 - NO INFORMATION WAS PROVIDED ON ANY PLASTIC SURGERY APPOINTMENTS PRIOR TO THIS SURGERY, ON INFORMED CONSENT SURGERY FORM OR POST-SURGERY REGARDING THE RESTRICTION OF NOT HAVING AN MRI COMPLETED. ASKED BY RN TO SIGN A BLANK INFORMED CONSENT. I HAD MULTIPLE SCLEROSIS (MS) PRIOR TO CANCER AND STATED AT MY PRE-SURGERY APPOINTMENTS THAT I HAD MY MS MEDICATION HALTED WITH THE POTENTIAL OF CANCER SECONDARILY TO THIS (LATER NOTED NOT RELATED TO HER 2+ CANCER DIAGNOSIS). WHEN I AM NOT TAKING ANY MS MEDICATIONS, MY NEUROLOGIST PREFERS TO HAVE A BRAIN MRI COMPLETED EVERY 6 MONTHS TO MONITOR ANY PROGRESSION IN POTENTIAL BR

  Patient problems: Insufficient Information

  MAUDE report 16952647 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "INFECTION". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 13233034 ↗
• InjuryJul 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION OF A TISSUE EXPANDER DUE TO ONE OF THE TABS BREAKING OFF. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12203688 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 12160357 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12156969 ↗
• InjuryOct 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Failure of Implant

  MAUDE report 10697614 ↗