IDEAL IMPLANT 63501Recalls & reported problems
Ideal Implant Incorporated · Round, smooth-surface, saline-filled breast implant. · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10851795006121), received between May 4, 2018 and Apr 17, 2023 — classified as 19 injuries, 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (16 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 16, 2026.
Most reported problems
Device problems
- Deflation Problem16
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Known Impact Or Consequence To Patient6
- Insufficient Information5
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions2
- Capsular Contracture1
- No Code Available1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16756375 ↗InjurySep 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15511794 ↗InjuryJul 6, 2022Deflation Problem
InjuryFeb 9, 2022Deflation Problem
InjuryJan 5, 2022Deflation Problem
InjuryJun 15, 2021Deflation Problem
InjuryMay 4, 2021Deflation Problem
InjuryMay 4, 2021Deflation Problem
InjuryJan 21, 2021Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: Insufficient Information
MAUDE report 11210827 ↗InjuryOct 24, 2020Deflation Problem
ALLEGED DEFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10731897 ↗InjuryAug 23, 2020Deflation Problem
ALLEGED DEFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10440618 ↗InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem
INFECTION AND SURGERY COMPLICATION RESULTING IN EXPLANTATION.
Patient problems: Unspecified Infection
MAUDE report 10151171 ↗InjuryMay 15, 2020Deflation Problem
ALLEGED DEFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10063816 ↗InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem
InjuryJan 13, 2020Deflation Problem; Appropriate Device Problem Term/Code Not Available
InjuryDec 2, 2019Deflation Problem
InjuryJun 24, 2019Deflation Problem
InjuryMar 25, 2019Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8450243 ↗MalfunctionMar 1, 2019Deflation Problem
DEFLATION RESULTING IN EXPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8383616 ↗InjuryMay 4, 2018Deflation 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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