AMS AmbicorRecalls & reported problems across all models
Boston Scientific Corporation · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 491
- Deaths reported
- 0
- Injuries reported
- 414
- Recalls
- 0
We found 9 models of AMS Ambicor by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 491 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2018 and Sep 30, 2026 — classified as 414 injuries, 77 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (175 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AMS Ambicor problems
Device problems
- Inflation Problem175
- Mechanical Problem130
- Adverse Event Without Identified Device or Use Problem96
- Fluid/Blood Leak84
- Deflation Problem77
- Insufficient Device Problem Information43
- Degraded40
- Defective Device31
Patient problems
- No Clinical Signs, Symptoms or Conditions221
- No Known Impact Or Consequence To Patient108
- Unspecified Infection45
- Pain41
- No Consequences Or Impact To Patient40
- Erosion33
- Discomfort12
- Insufficient Information9
AMS Ambicor models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS Ambicor 72401452Device, Impotence, Mechanical/Hydraulic153 reports
- AMS Ambicor 72401451Device, Impotence, Mechanical/Hydraulic117 reports
- AMS Ambicor 72401455Device, Impotence, Mechanical/Hydraulic75 reports
- AMS Ambicor 72401454Device, Impotence, Mechanical/Hydraulic57 reports
- AMS Ambicor 72401450Device, Impotence, Mechanical/Hydraulic52 reports
- AMS Ambicor 72401453Device, Impotence, Mechanical/Hydraulic24 reports
- AMS Ambicor 72401457Device, Impotence, Mechanical/Hydraulic6 reports
- AMS Ambicor 72401458Device, Impotence, Mechanical/Hydraulic5 reports
- AMS Ambicor 72401456Device, Impotence, Mechanical/Hydraulic2 reports
Recent AMS Ambicor adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Deflation Problem
Patient problems: Discomfort; Pain
MAUDE report 50952826 ↗InjurySep 4, 2026Inadequacy of Device Shape and/or Size
It was reported that the patient experienced floppy glans and stated that the Ambicor Penile Prosthesis (APP) was not long enough. A revision procedure was performed during which the APP was explanted, the patient was re-sized, and a 21 cm CX device was implanted. No additional patient complications were reported.
Patient problems: Deformity/ Disfigurement
MAUDE report 50602253 ↗InjuryAug 3, 2026Degraded; Mechanical Problem
It was reported that this Ambicor Penile Prosthesis (APP) was not working properly. Upon inspection, an aneurysm of the cylinder was identified, and fluid was not returning to the reservoir as expected. As a result, the device was explanted and replaced. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123743 ↗InjuryJun 30, 2026Inflation Problem; Unintended Deflation
IT WAS REPORTED THAT THE PATIENT'S AMBICOR PENILE PROSTHESIS (APP) WAS NOT FUNCTIONING PROPERLY, THE DEVICE EXHIBITED INFLATION ISSUES AND SPONTANEOUS DEFLATION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE APP WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673575 ↗InjuryMay 19, 2026Mechanical Problem
IT WAS REPORTED THAT THE PATIENT'S AMBICOR PENILE PROSTHESIS (APP) WAS NOT FUNCTIONING AS INTENDED. A SURGICAL PROCEDURE WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE APP WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25224924 ↗MalfunctionApr 21, 2026Deflation Problem
IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) STATED THAT HE WAS UNABLE TO DEFLATE THE LEFT SIDE OF THE DEVICE. THE PATIENT WAS SUGGESTED TO CONTACT HIS UROLOGIST FOR NEXT STEPS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948320 ↗InjuryApr 13, 2026Deflation Problem; Inflation Problem; Nonstandard Device
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE OR DEFLATE THE DEVICE DUE TO A BLOCKED CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859401 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED AN INFECTION, DURING WHICH THE PUMP BEGAN TO ERODE THROUGH THE SKIN. A SURGICAL INTERVENTION WAS PERFORMED, AND NO DEVICE ISSUES WERE IDENTIFIED. THE APP WAS SUBSEQUENTLY REPLACED, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Erosion; Unspecified Infection
MAUDE report 24563848 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) EXPERIENCED PAIN AND DEVELOPED A SCROTAL INFECTION. UPON INSPECTION, PUS WAS OBSERVED AND CULTURES WERE SENT FOR PATHOLOGY. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP AND REPLACE IT WITH A TACTRA MALLEABLE DEVICE. HOWEVER, DURING CLOSURE, A URETHRAL INJURY WAS IDENTIFIED, UNRELATED TO THE DEVICE, PROMPTING THE PHYSICIAN TO REMOVE THE TACTRA DEVICE WITHOUT PLACING A NEW IMPLANT. THE INFECTION WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Purulent Discharge; Unspecified Infection
MAUDE report 24464148 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS AMBICOR PENILE PROSTHESIS (APP) DEVELOPED AN INFECTION IN THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP, AND A TACTRA DEVICE WAS TEMPORARILY IMPLANTED; INFECTION WAS TREATED WITH ANTIBIOTICS. SEVERAL MONTHS LATER, AFTER THE INFECTION RESOLVED, THE TACTRA WAS REPLACED WITH A THREE-PIECE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 24259404 ↗InjuryJan 20, 2026Deflation Problem; Mechanical Problem; Nonstandard Device
IT WAS REPORTED THAT THE PATIENT'S AMBICOR PENILE PROSTHESIS (APP) WAS NOT FUNCTIONING PROPERLY AS IT EXHIBITED DEFLATION ISSUES. ADDITIONALLY, THE PUMP WAS RIGID AND UNABLE TO BE PUMPED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE APP, AND AT A LATER TIME, A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24122611 ↗InjuryJan 8, 2026Inflation Problem; Nonstandard Device
IT WAS REPORTED THAT THIS AMBICOR PENILE PROSTHESIS (APP) WAS NOT INFLATING PROPERLY, AND THE PATIENT EXPRESSED DISSATISFACTION WITH THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE AMBICOR IMPLANT WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24007102 ↗InjuryJan 6, 2026Degraded; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE CYLINDER OF THIS AMBICOR PENILE PROSTHESIS (APP) HAD A PUNCTURE, ANEURYSM AND FLUID LOSS. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981083 ↗InjuryJan 5, 2026Deflation Problem; Mechanical Problem
IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) PRESENTED FOR A FOLLOW UP APPOINTMENT IN 2025, DURING WHICH A PUMPING ISSUE WAS IDENTIFIED. THE LEFT CYLINDER FAILED TO DEFLATE AND REMAINED INFLATED IN THE RESTING POSITION. A REVISION SURGERY WAS PERFORMED IN WHICH THE DEVICE WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23970647 ↗InjuryDec 29, 2025Inflation Problem; Mechanical Problem; Nonstandard Device; Inflation Problem; Mechanical Problem; Nonstandard Device
IT WAS REPORTED THAT A PATIENT WITH AN AMBICOR PENILE PROSTHESIS (APP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED THE DEVICE AND REPLACED IT WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23916958 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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