MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZHPB740SRecalls & reported problems
Mentor Texas L.P. · High Profile BOOST, For Use With SHPB-740 · Class U
All models of MENTOR MemoryGel Breast Implants (368)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317027522), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Disintegration” (1 report).
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.
Most reported problems
Device problems
- Material Disintegration1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2022Material Disintegration; Material Rupture; Material Disintegration; Material Rupture
IT WAS REPORTED THAT TWO MENTOR MEMORYGEL BOOST RESTERILIZABLE GEL SIZERS BEING USED IN A BREAST AUGMENTATION WERE FOUND TO BE RUPTURED DURING THE OPERATION. THE DEVICES DID COME INTO CONTACT WITH THE PATIENT; HOWEVER, THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14655433 ↗
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
- MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZHPB480SMentor Texas L.P. · SIZER, MAMMARY, BREAST IMPLANT VOLUME3 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
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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