IDEAL IMPLANT 24001Recalls & 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 is a round, smooth breast implant. The 95 reports mostly describe deflation of one or both implants, sometimes partial or suspected. They name 92 injuries and no deaths. There are no recalls for this device. Reports naming it fell from 7 in the prior 12 months to 0 in the last 12 months.
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
- 95
- Deaths reported
- 0
- Injuries reported
- 92
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10851795006015), received between Jul 3, 2018 and Feb 8, 2025 — classified as 92 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (36 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 Problem36
- Adverse Event Without Identified Device or Use Problem19
- Insufficient Device Problem Information13
- Unintended Deflation11
- Material Rupture6
- Appropriate Device Problem Term/Code Not Available4
- Patient Device Interaction Problem4
- Inflation Problem3
Patient problems
- Insufficient Information24
- Capsular Contracture20
- No Clinical Signs, Symptoms or Conditions16
- No Known Impact Or Consequence To Patient16
- Failure of Implant14
- Deformity/ Disfigurement2
- No Code Available2
- Hematoma1
Recent adverse event reports
The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2025Unintended Deflation; Unintended Deflation
InjuryFeb 8, 2025Unintended Deflation; Unintended Deflation
SUSPECTED DEFLATION OF LEFT BREAST IMPLANT
Patient problems: Failure of Implant
MAUDE report 21340216 ↗InjuryJan 9, 2025Unintended Deflation; Unintended Deflation
PARTIAL DEFLATION SUSPECTED ON RIGHT BREAST IMPLANT.
Patient problems: Failure of Implant
MAUDE report 21120958 ↗InjuryJan 9, 2025Unintended Deflation; Unintended Deflation
InjuryJan 8, 2025Unintended Deflation; Unintended Deflation
InjuryNov 13, 2024Unintended Deflation; Unintended Deflation
InjuryNov 2, 2024Unintended Deflation; Unintended Deflation
InjuryOct 19, 2024Unintended Deflation; Unintended Deflation
CUSTOMER CALLED FOR DEFLATION, REQUESTED FOR IMPLANT AND EXPLANT KIT.
Patient problems: Failure of Implant
MAUDE report 20488906 ↗InjuryOct 3, 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 17132162 ↗InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132051 ↗InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16473137 ↗InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16473077 ↗InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16473028 ↗InjuryMar 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464386 ↗InjuryJan 25, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
CAPSULE CONTACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16241941 ↗InjuryJan 25, 2023Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
InjuryOct 31, 2022Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15705011 ↗InjuryOct 31, 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 15704525 ↗InjuryOct 17, 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 15617304 ↗InjuryOct 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15557609 ↗InjuryOct 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15557533 ↗InjurySep 30, 2022Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15511737 ↗InjurySep 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULAR CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15439083 ↗InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392801 ↗
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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