IDEAL IMPLANT 27001Recalls & reported problems
Ideal Implant Incorporated · Round, smooth-surface, saline-filled breast implant. · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Ideal Implant saline breast implant has 138 adverse event reports, with no deaths and 133 injuries. Most describe the implant losing its saline and deflating, and some describe capsular contracture. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 138
- Deaths reported
- 0
- Injuries reported
- 133
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10851795006022), received between Apr 17, 2018 and Feb 8, 2025 — classified as 133 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (77 reports).
1 other recall cover devices cleared under the same FDA submission (P120011); 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
- Deflation Problem77
- Insufficient Device Problem Information21
- Adverse Event Without Identified Device or Use Problem12
- Material Rupture11
- Unintended Deflation9
- Burst Container or Vessel4
- Appropriate Device Problem Term/Code Not Available3
- Material Perforation3
Patient problems
- Insufficient Information48
- No Known Impact Or Consequence To Patient32
- No Clinical Signs, Symptoms or Conditions22
- Failure of Implant17
- Capsular Contracture13
- No Code Available7
- No Information1
Recent adverse event reports
The 25 most recent of 138 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2025Unintended Deflation; Unintended Deflation
InjuryFeb 8, 2025Unintended Deflation; Unintended Deflation
InjuryJan 6, 2025Unintended Deflation; Unintended Deflation
InjuryAug 27, 2024Unintended Deflation; Unintended Deflation
InjuryAug 27, 2024Unintended Deflation; Unintended Deflation
InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132168 ↗InjuryJun 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132167 ↗InjuryJun 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17084772 ↗InjuryMay 2, 2023Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857692 ↗InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16855928 ↗InjuryApr 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704978 ↗InjuryApr 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704975 ↗InjuryMar 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464379 ↗InjuryFeb 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16441125 ↗InjuryJan 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryDec 13, 2022Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973655 ↗InjuryDec 5, 2022Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15920605 ↗InjuryNov 18, 2022Peeled/Delaminated; Insufficient Device Problem Information; Peeled/Delaminated; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15829513 ↗InjuryNov 18, 2022Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15829101 ↗InjuryNov 18, 2022Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15828546 ↗InjuryOct 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15651056 ↗InjuryOct 17, 2022Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15617565 ↗InjuryOct 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15617302 ↗InjurySep 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15440980 ↗InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392818 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P120011. One submission often covers many models, so check the product and lot details in each record.
- Z-2219-2019 · Mar 18, 2019 · TerminatedIDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc,
Other Prosthesis, Breast, Inflatable, Internal, Saline devices
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 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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