MENTOR Tissue Expander 3505305MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317002581), received between May 17, 2018 and Nov 19, 2020 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABDOMINOPLASTY WITH A MENTOR TISSUE EXPANDER AND EXPERIENCED DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2020.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 10870563 ↗
• InjuryNov 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A MENTOR TISSUE EXPANDER 250CC AND SUFFERED FROM A DEFLATION OF THE TISSUE EXPANDER. THE PATIENT EXPERIENCED: ¿A BUBBLE UNDER THE SKIN NEXT TO THE TISSUE EXPANDER. NO INFECTION WAS REPORTED¿. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2020.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 10774977 ↗
• MalfunctionJun 25, 2020Filling Problem; Filling Problem

  IT WAS REPORTED THAT DURING A BREAST PROSTHESIS IMPLANTATION SURGERY ON (B)(6) 2020, A 250 CC MENTOR TISSUE EXPANDER COULD NOT BE FILLED INTRAOPERATIVELY. AS A RESULT, ANOTHER TISSUE EXPANDER WAS UTILIZED WITHOUT ANY ISSUE. NO PATIENT CONSEQUENCE OR ADVERSE EVENT WAS REPORTED.

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

  MAUDE report 10195820 ↗
• InjuryAug 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO IMPLANTATION, A MENTOR TISSUE EXPANDER 250CC WAS FOUND TO BE DEFLATED WHILE IN PREPARATION. NO DELAYS IN SURGERY WERE REPORTED. THE PATIENT UNDERWENT IMPLANTATION WITH A MENTOR TISSUE EXPANDER 250CC, SERIAL NUMBER (B)(4) AS A REPLACEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8941830 ↗
• InjuryAug 28, 2019Inflation Problem; Inflation Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED SURGERY WITH A MENTOR TISSUE EXPANDER 250CC DEVICE THAT WAS DIFFICULT TO EXPAND. IN ADDITION, THERE WAS A SPILL OF PHYSIOLOGICAL SOLUTION. THIS ISSUE WAS REPORTED FOR THE LEFT BREAST DEVICE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 8940435 ↗
• InjuryMar 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A RECONSTRUCTIVE SKIN SURGERY ON THE THIGH USING TWO EXPANDERS WITH A MENTOR TISSUE EXPANDER 250CC AND THE PATIENT EXPERIENCED PAIN AND ONE OF THE DEVICES LEAKED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT OF BOTH IMPLANTS WITH MENTOR TISSUE EXPANDERS 150CC, CATALOG NUMBER 3505304M, LOT NUMBER 7381670, SERIAL NUMBER (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available; Pain

  MAUDE report 8462414 ↗
• InjuryMay 17, 2018Off-Label Use; Material Rupture; Use of Device Problem; Off-Label Use; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR TISSUE EXPANDER 250CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE DEFLATION WAS IN THE MIDDLE OF THE EXPANDER IN THE JOINT AT THE EXPANDER PAD. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018. THE EXPLANTED DEVICE WAS NOT REPLACED.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 7524531 ↗