IDEAL IMPLANT 30001Recalls & reported problems
Ideal Implant Incorporated · Round, smooth-surface, saline-filled breast implant. · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ideal Implant is a round, smooth saline-filled breast implant. Many of the 136 reports describe the saline implant deflating, and some mention ruptures and capsular contracture, meaning tightening of the scar tissue around the implant. There are no deaths and 131 injuries. 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
- 136
- Deaths reported
- 0
- Injuries reported
- 131
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 10851795006039), received between Jan 20, 2017 and Feb 24, 2025 — classified as 131 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (72 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem72
- Adverse Event Without Identified Device or Use Problem19
- Insufficient Device Problem Information17
- Material Rupture15
- Unintended Deflation7
- Failure to Fold3
- Patient Device Interaction Problem3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Insufficient Information47
- No Known Impact Or Consequence To Patient26
- No Clinical Signs, Symptoms or Conditions21
- Failure of Implant19
- Capsular Contracture14
- No Code Available6
- Deformity/ Disfigurement2
- No Information2
Recent adverse event reports
The 25 most recent of 136 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2025Unintended Deflation; Unintended Deflation
InjuryFeb 3, 2025Infusion or Flow Problem; Infusion or Flow Problem
SUSPECTED VALVE PLACEMENT ISSUE DURING SURGERY.
Patient problems: Failure of Implant
MAUDE report 21298495 ↗InjuryJan 9, 2025Unintended Deflation; Unintended Deflation
InjuryJun 12, 2024Unintended Deflation; Unintended Deflation
InjuryJun 12, 2024Unintended Deflation; Unintended Deflation
InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
InjuryJun 14, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
InjuryMay 2, 2023Failure 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 16855925 ↗InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16855924 ↗InjuryApr 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704968 ↗InjuryFeb 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16441120 ↗InjuryJan 11, 2023Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
InjuryJan 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16142374 ↗InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973668 ↗InjuryDec 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973617 ↗InjuryDec 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973605 ↗InjuryDec 5, 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 15920740 ↗InjuryNov 1, 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 15710784 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15704323 ↗InjuryOct 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15557617 ↗InjurySep 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15511514 ↗InjurySep 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15408402 ↗InjurySep 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15408401 ↗InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392819 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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