IDEAL IMPLANT 37001Recalls & 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 is used for breast augmentation. Its 257 reports mostly describe the implant deflating, with some reporting material rupture. There were no deaths and 238 injuries, and reports dropped to 0 in the last 12 months from 11 in the 12 months before. 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
- 257
- Deaths reported
- 0
- Injuries reported
- 238
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 257 adverse event reports that list this exact device (DI 10851795006053), received between Feb 6, 2016 and Jun 5, 2025 — classified as 238 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (134 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 Problem134
- Insufficient Device Problem Information30
- Unintended Deflation29
- Adverse Event Without Identified Device or Use Problem27
- Material Rupture14
- Burst Container or Vessel8
- Appropriate Device Problem Term/Code Not Available7
- Patient Device Interaction Problem6
Patient problems
- Insufficient Information82
- No Known Impact Or Consequence To Patient54
- Failure of Implant39
- No Clinical Signs, Symptoms or Conditions36
- Capsular Contracture23
- No Code Available11
- No Information6
- Deformity/ Disfigurement5
Recent adverse event reports
The 25 most recent of 257 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2025Unintended Deflation; Unintended Deflation
InjuryMay 12, 2025Unintended Deflation; Unintended Deflation
SUSPECTED RIGHT BREAST IMPLANT DEFLATION.
Patient problems: Failure of Implant
MAUDE report 22002815 ↗InjuryMar 18, 2025Unintended Deflation; Unintended Deflation
InjuryMar 11, 2025Unintended Deflation; Unintended Deflation
InjuryFeb 24, 2025Unintended Deflation; Unintended Deflation
InjuryFeb 24, 2025Unintended Deflation; Unintended Deflation
SUSPECTED DEFLATION OF THE BREAST IMPLANT.
Patient problems: Failure of Implant
MAUDE report 21446897 ↗InjuryFeb 3, 2025Unintended Deflation; Unintended Deflation
InjuryJan 14, 2025Unintended Deflation; Unintended Deflation
InjuryDec 13, 2024Unintended Deflation; Unintended Deflation
InjuryNov 22, 2024Unintended Deflation; Unintended Deflation
InjuryNov 2, 2024Unintended Deflation; Unintended Deflation
InjuryOct 19, 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 20488905 ↗InjuryOct 3, 2024Unintended Deflation; Unintended Deflation
InjuryJun 12, 2024Unintended Deflation; Unintended Deflation
THERE IS A VISIBLE DEFLATION ON HER RIGHT BREAST. PATIENT DENIES ANY MANIPULATION OR TRAUMA.
Patient problems: Failure of Implant
MAUDE report 19525210 ↗InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132043 ↗InjuryJun 8, 2023Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
InjuryMay 2, 2023Insufficient 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 16855927 ↗InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16855922 ↗InjuryMay 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16855921 ↗InjuryApr 17, 2023Peeled/Delaminated; Insufficient Device Problem Information; Peeled/Delaminated; Insufficient Device Problem Information
InjuryApr 17, 2023Failure to Fold; Insufficient Device Problem Information; Failure to Fold; Insufficient Device Problem Information
InjuryMar 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16525840 ↗InjuryMar 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16525815 ↗InjuryJan 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16186407 ↗
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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