Natrelle INSPIRA Resterilizable SizersRecalls & reported problems across all models
Allergan, Inc. · 20 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 20 models of Natrelle INSPIRA Resterilizable Sizers by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and May 26, 2026 — classified as 17 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Natrelle INSPIRA Resterilizable Sizers problems
Device problems
- Material Rupture16
- Difficult to Open or Remove Packaging Material8
- Break4
- Device Handling Problem3
- Improper or Incorrect Procedure or Method2
- Adverse Event Without Identified Device or Use Problem1
- Contamination1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Failure of Implant22
- No Clinical Signs, Symptoms or Conditions10
- Capsular Contracture1
- Necrosis1
- No Information1
- No Known Impact Or Consequence To Patient1
- Purulent Discharge1
- Unspecified Infection1
Natrelle INSPIRA Resterilizable Sizers models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Natrelle INSPIRA Resterilizable Sizers MSZ-F450Mammary Sizer6 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F385Mammary Sizer4 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F335Mammary Sizer3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F560Mammary Sizer3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F415Mammary Sizer2 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-X445Mammary Sizer2 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-LP145Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-M405Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-F295Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-F365Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-F485Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-F520Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-F605Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-F770Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-X285Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-X375Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-X525Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-X545Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-X615Mammary Sizer1 report
- Natrelle INSPIRA Resterilizable Sizers MSZ-X700Mammary Sizer1 report
Recent Natrelle INSPIRA Resterilizable Sizers adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED DIFFICULTIES OPENING A SIZER, THE PAPER FROM THE OUTSIDE WRAP AND ADHESIVE WOULD NOT COMPLETELY PEEL OFF AND THEREFORE WOULDN'T ALLOW ACCESS THE SIZER CONTAINER WITHOUT CONTAMINATION TO HIS GLOVES AND THE SURGICAL FIELD. THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 25288339 ↗MalfunctionMay 20, 2026Device Contaminated During Manufacture or Shipping
HEALTHCARE PROFESSIONAL REPORTED THROUGH A SALES REPRESENTATIVE A "HAIR ON THE SIZER". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25227531 ↗MalfunctionApr 20, 2026Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL THROUGH SALES REPRESENTATIVE REPORTED "SIZER TRAYS WERE COMPLETELY FUSED TOGETHER". DEVICE STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924633 ↗MalfunctionJan 16, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA A SALES REPRESENTATIVE "THERE WAS ANOTHER SIZER THAT WAS ALSO RUPTURED AFTER STERILIZATION AFTER JUST 5 CYCLES". THE DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 24093311 ↗InjurySep 25, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿OPENED A SIZER IN THE OR AND PLACED IT IN THE PATIENT, WITHOUT BEING PUNCTURED BY ANYTHING, THE SIZER BROKE". THERE WAS NO HARM TO THE PATIENT. HEALTHCARE PROFESSIONAL LATER REPORTED "THE IMPLANT WAS RUPTURED" AND "THE SHELL WAS DESTROYED AND SILICONE WAS SPILLING OUT/THE IMPLANT FELL APART". DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23143064 ↗MalfunctionSep 15, 2025Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem
SALES REPRESENTATIVE REPORTED ¿ISSUES WITH THE PAPER PEELING OFF, CAUSING STERILITY ISSUES WITH THE IMPLANT¿ AND COULD NOT BE OPENED. LATER HEALTHCARE PROFESSIONAL REPORTED "THE OUTER SHRINK WRAP PLASTIC AND BOX WERE UNDAMAGED. THE NURSE PEELED THE PAPER (THERMOFORM SEAL) FROM THE CLAM SHELL, AND IT ONLY PARTIALLY SEPARATED FROM THE PLASTIC SHELL, LEAVING BEHIND PAPER STILL FUSED TO THE OUTER CLAM SHELL. THE OUTER THERMOFORM SEAL DID NOT APPEAR DAMAGED BEFORE OPENING ON EITHER SHELL. I PERSONALLY TRIED TO EXTRACT THE INNER CLAMP SHELL FROM THE CONSTRUCT; HOWEVER, THE PAPER DID SEPARATE, AND I WAS UNABLE TO EXTRACT THE SIZER WITHOUT CONTAMINATION.". DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23053711 ↗MalfunctionSep 11, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
SALES REPRESENTATIVE REPORTED ¿ISSUES WITH THE PAPER PEELING OFF, CAUSING STERILITY ISSUES WITH THE IMPLANT¿ AND COULD NOT BE OPENED. LATER HEALTHCARE PROFESSIONAL REPORTED "THE BOX AND THE SHRINK WRAP PLASTIC AROUND THE BOX WERE UNDAMAGED. THEN THE NURSE ATTEMPTED TO OPEN THE INNER CLAMSHELL BY PEELING OFF THE PAPER (THERMOFORM). THE PAPER SPLIT IN TWO AND DID NOT SEPARATE FROM THE PLASTIC SHELL. IT DID NOT APPEAR DAMAGED. I CAN NOT COMMENT ON THE INNER SEAL BECAUSE WE NEVER GO TO SEE THAT ONE BECAUSE THE OUTER SEAL NEVER SEPARATED CORRECTLY.". DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23034100 ↗InjuryJun 23, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
COMPANY REPRESENTATIVE REPORTED THE BOX OF THE SIZER WAS MALFUNCTIONING AND REALLY HARD TO OPEN. LATER, HEALTHCARE PROFESSIONAL REPORTED "DEVICE PACKAGING DIFFICULT TO REMOVE, COMPROMISING STERILITY OF IMPLANT". DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22309309 ↗MalfunctionJun 20, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
COMPANY REPRESENTATIVE ON BEHALF OF HEALTHCARE PROFESSIONAL REPORTED THE BOX OF THE SIZER WAS MALFUNCTIONING AND REALLY HARD TO OPEN. LATER, HEALTHCARE PROFESSIONAL REPORTED "DEVICE PACKAGING DIFFICULT TO REMOVE, COMPROMISING STERILITY OF IMPLANT", NO PATIENT CONTACT. DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296100 ↗InjuryJun 3, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE FOR LEFT SIDE VIA MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22132287 ↗MalfunctionMay 15, 2025Break; Break
SALES REPRESENTATIVE REPORTED "RUPTURED GEL SIZER". DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22030224 ↗InjuryMay 5, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "A SIZER WAS OPENED AND THE TRAYS WERE COMPLETELY STUCK TOGETHER. THE INNER PAPER LID TORE AS THE SCRUB TECH STRUGGLED TO TAKE THE INNER TRAY FROM THE CIRCULATOR". "THE SURGEON HAD TO BREAK 1 TOUCH PROTOCOL TO REMOVE THE SIZER BY HAND FROM THE INNER TRAY" AND "THE TRAYS ARE COMPLETELY STUCK/FUSES TOGETHER AND CAN NOT BE SEPARATED". THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21961958 ↗InjuryApr 15, 2025Material Rupture; Material Rupture
PATIENT CONTACT OCCURRED AND THE DEVICE WAS NOT IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: Failure of Implant
MAUDE report 21842353 ↗MalfunctionApr 11, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
COMPANY REPRESENTATIVE REPORTED "BREAST SIZER WOULD NOT OPEN STERILELY. UNABLE TO USE PRODUCT". DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21826301 ↗MalfunctionJan 1, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". DEVICE WAS NOT IMPLANTED. PATIENT CONTACT WITH THE DEVICE OCCURRED. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: Failure of Implant
MAUDE report 21051402 ↗
Other Allergan, Inc. products
- Natrelle Breast Implants1,167 models · 38,972 reports · 7 recalls
- Natrelle INSPIRA Breast Implants197 models · 15,057 reports · 1 recall
- NATRELLE Saline-Filled Breast Implants103 models · 7,892 reports · 1 recall
- Natrelle Inspira SoftTouch Breast Implants195 models · 6,571 reports · 1 recall
- NATRELLE Silicone-Filled Breast Implants128 models · 4,507 reports · 1 recall
- Natrelle Inspira Cohesive Breast Implants192 models · 2,949 reports · 1 recall
- JUVEDERM ULTRA XC3 models · 550 reports
- JUVEDERM ULTRA PLUS XC2 models · 324 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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