IDEAL IMPLANT 67501Recalls & 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
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10851795006138), received between Apr 19, 2019 and Jul 3, 2024 — classified as 11 injuries, 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (6 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 Problem6
- Insufficient Device Problem Information3
- Burst Container or Vessel1
- Device Handling Problem1
- Material Rupture1
- Unintended Deflation1
Patient problems
- Insufficient Information4
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions3
- Failure of Implant1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2024Unintended Deflation; Unintended Deflation
PATIENT WAS SEEN IN OFFICE WITH LEFT SIDE DEFLATION.
Patient problems: Failure of Implant
MAUDE report 19672093 ↗InjuryMar 10, 2023Insufficient 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 16525627 ↗InjuryDec 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973675 ↗InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392817 ↗InjuryJul 11, 2022Deflation Problem
InjuryMar 1, 2022Deflation Problem
InjuryOct 18, 2021Deflation Problem
ALLEGED DEFLATION RESULTING IN EXPLANTATION.
Patient problems: Insufficient Information
MAUDE report 12647078 ↗InjuryApr 14, 2021Deflation Problem
InjuryAug 23, 2020Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10440620 ↗InjuryDec 2, 2019Burst Container or Vessel
InjuryJun 17, 2019Material Rupture
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8704630 ↗MalfunctionApr 19, 2019Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8533639 ↗
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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