MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZHPB480SRecalls & reported problems
Mentor Texas L.P. · High Profile BOOST, For Use With SHPB-480 · Class U
All models of MENTOR MemoryGel Breast Implants (368)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317027461), received between Jun 27, 2024 and Aug 15, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Inaccurate Information” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K062421); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Inaccurate Information3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2024Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT TWO 480CC MENTOR MEMORYGEL BOOST RESTERILIZABLE GEL SIZERS BEING USED IN A BREAST SURGERY WERE FOUND TO HAVE LABELING DISCREPANCIES DURING THE OPERATION. THE GEL SIZERS DID NOT TOUCH THE PATIENT. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. THIS REPORT IS FOR ONE OF TWO DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995572 ↗MalfunctionAug 15, 2024Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT TWO 480CC MENTOR MEMORYGEL BOOST RESTERILIZABLE GEL SIZERS BEING USED IN A BREAST SURGERY WERE FOUND TO HAVE LABELING DISCREPANCIES DURING THE OPERATION. THE GEL SIZERS DID NOT TOUCH THE PATIENT. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. THIS REPORT IS FOR TWO OF TWO DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995280 ↗MalfunctionJun 27, 2024Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT A 480CC MENTOR MEMORYGEL BOOST RESTERILIZABLE GEL SIZER WAS OBSERVED TO HAVE A LABELING DISCREPANCY REGARDING THE CATALOG NUMBER. ONE SIDE OF THE DEVICE INDICATED THE SIZER WAS TO BE USED TO SIZE FOR SMPB CATALOGS WHILE THE OTHER SIDE INDICATED THE SIZER ITSELF WAS A SIZER FOR SHPB CATALOGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629047 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062421. One submission often covers many models, so check the product and lot details in each record.
- Z-0964-2015 · Dec 11, 2014 · TerminatedMENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Other SIZER, MAMMARY, BREAST IMPLANT VOLUME devices
- Natrelle INSPIRA Resterilizable Sizers MSZ-F450Allergan, Inc. · Mammary Sizer6 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F385Allergan, Inc. · Mammary Sizer4 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F560Allergan, Inc. · Sizer, Mammary, Breast Implant Volume3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F560Allergan, Inc. · Mammary Sizer3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F335Allergan, Inc. · Mammary Sizer3 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F295Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X560Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X495Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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