IDEAL IMPLANT 21001Recalls & 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 21001 is a round, smooth saline-filled breast implant placed inside the chest. The 58 reports mostly describe the implant losing its saline and flattening, with some mention of the shell breaking or rupturing, and patients also reporting hardening and shrinkage of the surrounding scar tissue. There are 56 injuries and no deaths, and 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
- 58
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10851795006008), received between Jun 7, 2018 and Mar 28, 2025 — classified as 56 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (34 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 Problem34
- Adverse Event Without Identified Device or Use Problem8
- Insufficient Device Problem Information6
- Unintended Deflation6
- Burst Container or Vessel2
- Material Rupture2
- Loss of or Failure to Bond1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information20
- No Known Impact Or Consequence To Patient11
- Failure of Implant9
- Capsular Contracture8
- No Clinical Signs, Symptoms or Conditions6
- No Code Available3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Information1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2025Unintended Deflation; Unintended Deflation
SUSPECTED DEFLATION OF LEFT BREAST IMPLANT.
Patient problems: Failure of Implant
MAUDE report 21724902 ↗InjuryJan 6, 2025Unintended Deflation; Unintended Deflation
InjuryAug 27, 2024Unintended Deflation; Unintended Deflation
InjuryAug 9, 2024Unintended Deflation; Unintended Deflation
InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16473013 ↗InjuryFeb 26, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
InjuryNov 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15828612 ↗InjuryOct 21, 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 15650518 ↗InjuryOct 21, 2022Loss of or Failure to Bond; Insufficient Device Problem Information; Loss of or Failure to Bond; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15650514 ↗InjurySep 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341659 ↗InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem
InjuryJul 13, 2022Deflation Problem
InjuryJun 21, 2022Unintended Deflation
InjuryMay 12, 2022Deflation Problem
InjuryMay 11, 2022Deflation Problem
InjuryMay 9, 2022Deflation Problem
InjuryApr 29, 2022Deflation Problem
InjuryApr 20, 2022Deflation Problem
InjuryApr 5, 2022Deflation Problem
InjuryApr 5, 2022Deflation Problem
InjuryMar 15, 2022Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: Insufficient Information
MAUDE report 13776753 ↗InjuryFeb 7, 2022Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13472682 ↗InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem
CAPSULE CONTRACTURE RESULTING IN EXPLANTATION.
Patient problems: Capsular Contracture
MAUDE report 13343939 ↗InjuryNov 17, 2021Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: Insufficient Information
MAUDE report 12832406 ↗InjuryNov 17, 2021Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: Insufficient Information
MAUDE report 12832402 ↗
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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