IDEAL IMPLANT 33501Recalls & 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 205 adverse event reports: no deaths and 197 injuries. Most reports describe suspected deflation or rupture of the implant, and some mention 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
- 205
- Deaths reported
- 0
- Injuries reported
- 197
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 10851795006046), received between Jul 19, 2016 and Feb 2, 2026 — classified as 197 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (99 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 Problem99
- Insufficient Device Problem Information35
- Adverse Event Without Identified Device or Use Problem26
- Unintended Deflation23
- Material Rupture11
- Burst Container or Vessel6
- Appropriate Device Problem Term/Code Not Available4
- Failure to Fold4
Patient problems
- No Known Impact Or Consequence To Patient52
- Insufficient Information48
- No Clinical Signs, Symptoms or Conditions39
- Failure of Implant33
- Capsular Contracture20
- No Code Available11
- Deformity/ Disfigurement2
- Double Capsule1
Recent adverse event reports
The 25 most recent of 205 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2026Unintended Deflation
InjuryMay 12, 2025Unintended Deflation; Unintended Deflation
InjuryApr 21, 2025Unintended Deflation; Unintended Deflation
SUSPECTED DEFLATION BEFORE IMPLANT SURGERY.
Patient problems: Failure of Implant
MAUDE report 21877965 ↗InjuryApr 21, 2025Unintended Deflation; Unintended Deflation
InjuryApr 1, 2025Unintended Deflation; Unintended Deflation
InjuryMar 18, 2025Unintended Deflation; Unintended Deflation
SUSPECTED PARTIAL DEFLATION OF LEFT BREAST IMPLANT.
Patient problems: Failure of Implant
MAUDE report 21636185 ↗InjuryFeb 24, 2025Unintended Deflation; Unintended Deflation
SUSPECTED RIGHT BREAST IMPLANT DEFLATION.
Patient problems: Failure of Implant
MAUDE report 21447373 ↗InjuryFeb 3, 2025Unintended Deflation; Unintended Deflation
InjuryJan 6, 2025Unintended Deflation; Unintended Deflation
InjuryNov 2, 2024Unintended Deflation; Unintended Deflation
PATIENT NOTICED LOSS IN VOLUME. SUSPECTED DEFLATION.
Patient problems: Failure of Implant
MAUDE report 20594007 ↗InjuryAug 27, 2024Unintended Deflation; Unintended Deflation
InjuryJul 17, 2024Unintended Deflation; Unintended Deflation
THERE IS A LEAK IN THE IMPLANT LEADING TO IMPLANT DEFLATION IN BOTH RIGHT AND LEFT IMPLANTS.
Patient problems: Failure of Implant
MAUDE report 19767922 ↗InjuryDec 23, 2023Unintended Deflation; Unintended Deflation
BILATERAL DEFLATION OF SALINE BREAST IMPLANTS.
Patient problems: Failure of Implant
MAUDE report 18389451 ↗InjuryDec 13, 2023Unintended Deflation; Unintended Deflation
InjuryOct 25, 2023Unintended Deflation; Unintended Deflation
InjuryOct 25, 2023Unintended Deflation; Unintended Deflation
InjuryOct 3, 2023Unintended Deflation; Unintended Deflation
InjurySep 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjurySep 8, 2023Unintended Deflation; Unintended Deflation
PATIENT PRESENTED WITH DEFLATED SALINE LEFT BREAST IMPLANT, RIGHT IMPLANT INTACT AND WILL UNDERGO REMOVAL OF BILATERAL IMPLANTS.
Patient problems: Failure of Implant
MAUDE report 17714295 ↗InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132171 ↗InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132055 ↗InjuryJun 14, 2023Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
InjuryJun 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17054507 ↗InjuryJun 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17054504 ↗InjuryApr 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16756386 ↗
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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