IDEAL IMPLANT 44001Recalls & 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 round saline breast implant has 107 reports, no deaths and 101 injuries. Many reports describe the implant deflating, some suspected and some confirmed, and a few describe ruptures, while some describe capsular contracture, where scar tissue tightens around the implant. 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
- 107
- Deaths reported
- 0
- Injuries reported
- 101
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10851795006077), received between Nov 26, 2016 and Jan 9, 2025 — classified as 101 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (58 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 Problem58
- Adverse Event Without Identified Device or Use Problem16
- Insufficient Device Problem Information13
- Material Rupture8
- Burst Container or Vessel5
- Unintended Deflation4
- Appropriate Device Problem Term/Code Not Available3
- Material Split, Cut or Torn3
Patient problems
- Insufficient Information27
- No Known Impact Or Consequence To Patient27
- No Clinical Signs, Symptoms or Conditions16
- Failure of Implant14
- Capsular Contracture12
- No Code Available4
- Deformity/ Disfigurement2
- Hematoma2
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Unintended Deflation; Unintended Deflation
InjuryJan 8, 2025Unintended Deflation; Unintended Deflation
InjuryOct 19, 2024Unintended Deflation; Unintended Deflation
PATIENT REPORTED DEFLATION, RECEIVED NO INFO ABOUT THE SURGEON.
Patient problems: Failure of Implant
MAUDE report 20488908 ↗InjuryOct 3, 2024Unintended Deflation; Unintended Deflation
InjuryJun 8, 2023Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
InjuryMay 2, 2023Adverse 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 16856653 ↗InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16473101 ↗InjuryMar 1, 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 16464595 ↗InjuryFeb 26, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
InjuryFeb 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16441124 ↗InjuryJan 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16172366 ↗InjuryJan 11, 2023Loss 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 16142377 ↗InjuryNov 15, 2022Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15799463 ↗InjuryNov 7, 2022Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15746638 ↗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 15650525 ↗InjuryOct 6, 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 15557199 ↗InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392839 ↗InjurySep 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15349642 ↗InjuryJun 23, 2022No Apparent Adverse Event; Deflation Problem; No Apparent Adverse Event
ALLEGED DEFLATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14788857 ↗InjuryJun 22, 2022Material Rupture
InjuryJun 3, 2022Deflation Problem
InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem
InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem
CAPSULE CONTRACTURE RESULTING IN EXPLANTATION.
Patient problems: Capsular Contracture
MAUDE report 14208399 ↗InjuryMar 24, 2022Material Rupture
InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem
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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