AMS 700™ CX TENACIO™ Pump 72404433Recalls & reported problems
Boston Scientific Corporation · Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal · Class 3 · Implant
All models of AMS 700 CX TENACIO Pump (12)
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.
Quick summary
This AMS 700 inflatable penile prosthesis pump has 97 adverse event reports, with 90 injuries and no deaths. The reports mostly describe inflation and mechanical problems, including tubing breaks, plus infections, pain, discomfort, erosion, and swelling. There is 1 open recall, started September 2025, because devices may have inflation or deflation performance problems.
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
- 101
- Deaths reported
- 0
- Injuries reported
- 94
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00191506021344), received between Dec 3, 2024 and Sep 28, 2026 — classified as 94 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (43 reports).
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-0142-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Inflation Problem43
- Adverse Event Without Identified Device or Use Problem25
- Mechanical Problem20
- Migration13
- Fluid/Blood Leak12
- Material Puncture/Hole10
- Malposition of Device8
- Defective Device6
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Pain21
- Unspecified Infection19
- Discomfort13
- Erosion7
- Swelling/ Edema6
- Deformity/ Disfigurement4
- Purulent Discharge4
Recent adverse event reports
The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Inflation Problem; Mechanical Problem; Inadequacy of Device Shape and/or Size; Malposition of Device; Material Deformation
Patient problems: Discomfort; Pain
MAUDE report 50926226 ↗InjurySep 28, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920295 ↗InjurySep 23, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874339 ↗InjurySep 23, 2026Mechanical Problem; Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874052 ↗InjurySep 21, 2026Mechanical Problem; Migration
Patient problems: Deformity/ Disfigurement; Impaired Healing; Numbness; Pain
MAUDE report 50847392 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced scrotum pain. A surgical procedure was performed to remove and replace both cylinders and pump. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50696807 ↗InjurySep 8, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679510 ↗InjurySep 2, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568977 ↗InjuryAug 31, 2026Fluid/Blood Leak; Material Puncture/Hole
It was reported that the pump of this Inflatable Penile Prosthesis (IPP) presented a tubing break. A surgical procedure was performed during which the existing pump was explanted and replaced with a new one. There were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515482 ↗InjuryAug 20, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50360099 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed a scrotal infection. The physician observed obvious signs of swelling and redness. A surgical procedure was performed to remove and replace the IPP. The infection was treated with antibiotics. No further patient complications were reported.
Patient problems: Erythema; Swelling/ Edema; Unspecified Infection
MAUDE report 50306575 ↗InjuryAug 4, 2026Collapse; Inflation Problem; Failure to Deflate
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with difficulty inflating and deflating the device. The pump bulb did not fully or properly rebound. During a revision surgery, the pump was explanted and replaced, while the remaining device components were retained. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135791 ↗InjuryJul 31, 2026Inflation Problem; Material Deformation
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with an inability to inflate the device. A revision surgery was performed, during which the physician reported that the tubing was believed to be kinked, preventing the cylinders from filling properly. The device was explanted and replaced. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099507 ↗InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN INFECTION IN THE SCROTAL AREA. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND ALLOW THE PATIENT TIME TO HEAL, AND MEDICATION WAS PRESCRIBED. FOLLOWING RECOVERY, A NEW IPP WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 25602219 ↗InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INFLATABLE PENIS PROSTHESIS (IPP) PRESENTED WITH INFECTION AND A POSSIBLE HEMATOMA. A SURGICAL PROCEDURE WAS PERFORMED, AND THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AND NO ADDITIONAL INFORMATION COULD NOT BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Hematoma; Unspecified Infection
MAUDE report 25527255 ↗InjuryJun 11, 2026Inflation Problem; Mechanical Problem; Malposition of Device
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY AND EXHIBITED INFLATION ISSUES. A SURGICAL INTERVENTION WAS SUBSEQUENTLY PERFORMED, DURING WHICH IT WAS NOTED THAT, DURING THE INITIAL IMPLANTATION, THE RIGHT CYLINDER APPEARED TO HAVE BEEN IMPROPERLY POSITIONED. ADDITIONALLY, THE PUMP WAS FOUND TO BE POSITIONED HIGH WITHIN THE SCROTUM. THE IPP WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476605 ↗InjuryJun 10, 2026Inflation Problem; Nonstandard Device; Failure to Deflate
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) DIFFICULTY OPERATING THE PUMP, DEFLATING AND INFLATING, RESULTING IN PAIN AND DISCOMFORT IN THE SCROTUM. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR WAS RETAINED AND REUSED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Discomfort; Pain
MAUDE report 25461053 ↗InjuryJun 4, 2026Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) TUBING NEXT TO THE LEFT CYLINDER WAS BROKEN AND ALL FLUID WAS GONE. AS A RESULT, THE CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399423 ↗InjuryJun 3, 2026Inflation Problem; Mechanical Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) ATTENDED POST-OPERATIVE FOLLOW-UP VISITS AT THREE AND SIX WEEKS, DURING WHICH THE DEVICE WOULD NOT INFLATE. THE PHYSICIAN STATED THAT THE PRODUCT WAS DEFECTIVE. THE PATIENT FURTHER REPORTED OBTAINING A SECOND OPINION FROM ANOTHER PHYSICIAN, WHO ALSO STATED THAT THE PUMP WAS DEFECTIVE AND NEEDED TO BE REPLACED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND REPLACE IT WITH A NON-BOSTON SCIENTIFIC PRODUCT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385238 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A SWOLLEN SCROTUM, REDNESS, PAIN AND PRESENCE OF PUS. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED SCROTAL INFECTION AND EXPLANTED THE DEVICE. A WASHOUT WAS PERFORMED, AND THE DEVICE WAS REPLACED WITH A TACTRA DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Erythema; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection
MAUDE report 25250413 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PUMP EROSION THROUGH THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING IPP WAS EXPLANTED, A FULL WASHOUT WAS PERFORMED, THE PATIENT WAS REMEASURED, AND A TACTRA MALLEABLE PENILE PROSTHESIS WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Erosion
MAUDE report 25231166 ↗InjuryMay 14, 2026Inflation Problem; Mechanical Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE THAT DID NOT INFLATE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176471 ↗InjuryMay 13, 2026Malposition of Device
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT AND DISSATISFACTION WITH THE PUMP POSITION, STATING THAT IT WAS POSITIONED TOO LOW. AS A RESULT, THE PUMP WAS EXPLANTED, THE TUBING WAS SHORTENED, AND THE PUMP WAS REPOSITIONED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Discomfort
MAUDE report 25162862 ↗InjuryMay 6, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT HIS DEVICE WAS NOT INFLATING. UPON INSPECTION, A HOLE WAS IDENTIFIED IN THE RESERVOIR TO PUMP TUBING, ALONG WITH ASSOCIATED FLUID LOSS. AS A RESULT, THE PUMP AND CYLINDERS WERE EXPLANTED AND REPLACED. THE RESERVOIR WAS CAPPED AND A NEW RESERVOIR WAS IMPLANTED IN A DIFFERENT LOCATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25099515 ↗InjuryApr 7, 2026Inflation Problem
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED AUTO INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE TENACIO PUMP WAS REPLACED WITH AN MS PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24805309 ↗
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- AMS 700 LGX MS Pump 72404252-10Boston Scientific Corporation · Prosthesis, Penis, Inflatable561 reports
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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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