MENTOR Tissue Expander 3504302MRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317002383), received between Mar 5, 2019 and Mar 21, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (9 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.

• InjuryMar 21, 2025Component Missing; Component Missing

  A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR TISSUE EXPANDER EXP RECT REMOTE 250 CC SALINE PROSTHESIS EXPERIENCED FILL TUBING ISSUE INTRAOPERATION. THE EXPANDER CAME IN CONTACT, METAL PIECE USED TO RECONNECT TUBBING WHEN ADJUSTING LENGTH OF EXPANDER WAS MISSING, DR HAD TO REUSE THE PREVIOUS EXPANDER TUBBING TO COMPLETE THE PROCEDURE. THIS ISSUE CAUSED PROCEDURAL DELAY. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21666089 ↗
• MalfunctionOct 8, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE 250CC MENTOR TISSUE EXPANDER BOX WAS MISSING THE METAL CONNECTOR PIN UPON OPENING. THE PROCEDURE WAS PERFORMED BY USING ANOTHER DEVICE WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398660 ↗
• InjurySep 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 250CC MENTOR TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17741003 ↗
• InjurySep 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC MENTOR TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST TISSUE EXPANDER BY A MEDICAL PROFESSIONAL AS A HOLE/TEAR WAS OBSERVED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNDISCLOSED DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17729763 ↗
• InjuryJun 1, 2023Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A EXP RECT REMOTE 250CC AND EXPERIENCED A DEFLATION ON AN UNSPECIFIED SIDE POST-OPERATIVELY. THE DEVICE¿S USE IN A BREAST AUGMENTATION IS CONSIDERED OFF LABEL USE OF THE PRODUCT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION, BUT A SPECIFIC DATE WAS NOT PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17039875 ↗
• InjuryOct 20, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 250CC MENTOR TISSUE EXPANDER AND LEFT SIDE EXPANDER WAS FOUND TO BE DEFECTIVE. AS A RESULT, THE EXPANDER WAS EXPLANTED AT AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15642827 ↗
• InjurySep 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 250 CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15439914 ↗
• InjuryMar 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 250CC RECTANGULAR MENTOR TISSUE EXPANDER BEING USED IN A RECONSTRUCTION SURGERY WAS FOUND TO BE DEFLATED INTRA-OPERATIVELY. THERE WERE NO REPORTS OF PROCEDURAL DELAY OR PATIENT COMPLICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564023 ↗
• InjuryApr 30, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO 250CC MENTOR TISSUE EXPANDERS WERE ¿IMPACTED¿. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE OF TWO DEVICES.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10016324 ↗
• InjuryApr 30, 2020Material Rupture; Defective Device; Material Rupture; Defective Device

  IT WAS REPORTED THAT TWO 250CC MENTOR TISSUE EXPANDERS WERE ¿IMPACTED¿. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE OF TWO DEVICES.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10016307 ↗
• InjuryDec 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN LACERATION REPAIR PROCEDURE WITH A MENTOR TISSUE EXPANDER 250CC AND EXPERIENCED DEFLATION OF THE TISSUE EXPANDER. THE SIDE IS UNKNOWN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9513089 ↗
• InjuryMar 5, 2019Off-Label Use; Material Rupture; Use of Device Problem; Off-Label Use; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 250CC MENTOR TISSUE EXPANDER, EXPERIENCED LEFT SIDE DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 8392589 ↗