IDEAL IMPLANT 40501Recalls & 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-surface, saline-filled implant. It has 197 adverse event reports, with no deaths and 174 injuries, plus 23 malfunctions. Most describe the implant deflating, and some describe ruptures or hardened scar tissue. 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
- 197
- Deaths reported
- 0
- Injuries reported
- 174
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 10851795006060), received between Feb 6, 2016 and Feb 3, 2025 — classified as 174 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (107 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 Problem107
- Adverse Event Without Identified Device or Use Problem27
- Insufficient Device Problem Information18
- Material Rupture16
- Burst Container or Vessel10
- Appropriate Device Problem Term/Code Not Available8
- Unintended Deflation7
- Patient Device Interaction Problem5
Patient problems
- No Known Impact Or Consequence To Patient63
- Insufficient Information42
- Capsular Contracture26
- Failure of Implant21
- No Clinical Signs, Symptoms or Conditions21
- No Code Available17
- No Information7
- Deformity/ Disfigurement3
Recent adverse event reports
The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2025Unintended Deflation; Unintended Deflation
SUSPECTED PARTIAL DEFLATION IN LEFT BREAST IMPLANT.
Patient problems: Failure of Implant
MAUDE report 21298500 ↗InjuryNov 13, 2024Unintended Deflation; Unintended Deflation
InjuryJun 12, 2024Unintended Deflation; Unintended Deflation
PATIENT CLAIMED ONE IMPLANT FELT DEFLATED.
Patient problems: Failure of Implant
MAUDE report 19525221 ↗InjuryJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132054 ↗InjuryJun 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17054509 ↗InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16473086 ↗InjuryMar 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464387 ↗InjuryMar 1, 2023Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16464381 ↗InjuryJan 25, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
InjuryJan 17, 2023Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information
InjuryJan 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULE CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16186409 ↗InjuryJan 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16186405 ↗InjuryJan 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16172371 ↗InjuryJan 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJan 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16142375 ↗InjuryDec 5, 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 15920768 ↗InjuryNov 18, 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 15828557 ↗InjuryNov 7, 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 15744468 ↗InjuryOct 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15617285 ↗InjurySep 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULAR CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15439084 ↗InjurySep 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
CAPSULAR CONTRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15439082 ↗InjurySep 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15408407 ↗InjurySep 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15408400 ↗InjuryAug 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryAug 8, 2022Patient-Device Incompatibility
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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