AMS 700™ CXR TENACIO™ Pump 72404462Recalls & reported problems
Boston Scientific Corporation · Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal · Class 3 · Implant
All models of AMS 700 CXR TENACIO Pump (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506021511), received between Apr 23, 2025 and Dec 26, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Inflation Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 11, 2025Class IIOpen, Classified
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Z-0143-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Inflation Problem1
- Migration1
Patient problems
- Erosion1
- Pain1
- Post Operative Wound Infection1
- Unspecified Tissue Injury1
- Wound Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 26, 2025Migration; Migration
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS CROSSED OVER. AS A RESULT, THE CYLINDERS WERE EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION REPORTED.
Patient problems: Unspecified Tissue Injury
MAUDE report 23897437 ↗InjuryJun 2, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND WAS NOT SATISFIED WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) TENACIO PUMP. THE PATIENT STATED THAT IT IS MORE DIFFICULT TO INFLATE AND BULKIER THAN THE MS PUMP. THEREFORE, A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE COMPONENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain
MAUDE report 22122658 ↗InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS PRESENTED WITH AN OPEN INCISION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN SUSPECTED EROSION AND POSSIBLE INFECTION. THE DEVICE WAS REMOVED AND REPLACED WITH A MALLEABLE PROSTHESIS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Erosion; Post Operative Wound Infection; Wound Dehiscence
MAUDE report 21892361 ↗
Other Prosthesis, penis, inflatable devices
- AMS 700 MS Pump 72404310Boston Scientific Corporation · Prosthesis, Penis, Inflatable992 reports
- AMS 700 LGX MS Pump 72404252Boston Scientific Corporation · Prosthesis, Penis, Inflatable1 death757 reports
- AMS 700 CX MS Pump 72404233-12Boston Scientific Corporation · Prosthesis, Penis, Inflatable656 reports
- AMS 700 CX MS Pump 72404232Boston Scientific Corporation · Prosthesis, Penis, Inflatable639 reports
- AMS 700 LGX MS Pump 72404251Boston Scientific Corporation · Prosthesis, Penis, Inflatable611 reports
- Conceal 720185-01Boston Scientific Corporation · Prosthesis, Penis, Inflatable586 reports
- AMS 700 LGX MS Pump 72404252-10Boston Scientific Corporation · Prosthesis, Penis, Inflatable561 reports
- AMS 700 CX MS Pump 72404232-10Boston Scientific Corporation · Prosthesis, Penis, Inflatable533 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 · each recall links to the FDA recall notice
- 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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