AMS 700 CXR TENACIO PumpRecalls & 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
1 open recall names at least one AMS 700 CXR TENACIO Pump model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 1
We found 9 models of AMS 700 CXR TENACIO Pump by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 18 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2025 and Aug 20, 2026 — classified as 16 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (7 reports).
1 FDA recall record name at least one of these models by its device 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. 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
AMS 700 CXR TENACIO Pump recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 11, 2025Open, Classified
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Z-0143-2026 · Root cause: Nonconforming Material/Component · names 9 of these models · Recall details · FDA record ↗
Most reported AMS 700 CXR TENACIO Pump problems
Device problems
- Inflation Problem7
- Mechanical Problem5
- Adverse Event Without Identified Device or Use Problem3
- Migration3
- Deflation Problem2
- Inadequacy of Device Shape and/or Size2
- Insufficient Device Problem Information2
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Pain7
- Erosion2
- Unspecified Infection2
- Discomfort1
- Perforation1
- Post Operative Wound Infection1
- Purulent Discharge1
AMS 700 CXR TENACIO Pump models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS 700™ CXR TENACIO™ Pump 72404463Prosthesis, penis, inflatable1 recall7 reports
- AMS 700™ CXR TENACIO™ Pump 72404461Prosthesis, penis, inflatable1 recall3 reports
- AMS 700™ CXR TENACIO™ Pump 72404462Prosthesis, penis, inflatable1 recall3 reports
- AMS 700™ CXR TENACIO™ Pump 72404466Prosthesis, penis, inflatable1 recall2 reports
- AMS 700™ CXR TENACIO™ Pump 72404467Prosthesis, penis, inflatable1 recall2 reports
- AMS 700™ CXR TENACIO™ Pump 72404468Prosthesis, penis, inflatable1 recall1 report
- AMS 700™ CXR TENACIO™ Pump 72404464Prosthesis, penis, inflatable1 recall0 reports
- AMS 700™ CXR TENACIO™ Pump 72404465Prosthesis, penis, inflatable1 recall0 reports
- AMS 700™ CXR TENACIO™ Pump 72404469Prosthesis, penis, inflatable1 recall0 reports
Recent AMS 700 CXR TENACIO Pump adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351070 ↗InjuryAug 12, 2026Insufficient Device Problem Information
It was reported that the patient with an Inflatable Penile Prosthesis (IPP) experience achy pain in the scrotum. The event of pain has been resolved three weeks later. Additionally, the patient was dissatisfied with device due to perceived loss of penile length during an erection; however, is not related to the device and procedure. A surgical procedure was performed for the revision of one of the components of the IPP. Additionally, an infrapubic pannus resection was performed. No additional information.
Patient problems: Pain
MAUDE report 50223115 ↗InjuryAug 12, 2026Insufficient Device Problem Information
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) experienced post-operative pain and erosion. The tubing has protruded through tip of penis. The events of post-operative pain and erosion were resolved. A surgical procedure was performed to remove the IPP. No additional information was provided.
Patient problems: Erosion; Pain; Perforation
MAUDE report 50217366 ↗InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCROTAL PAIN. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN IDENTIFIED PURULENT MATERIAL (PUS) WITHIN THE SCROTUM, CONFIRMING THE PRESENCE OF AN INFECTION AT THE IMPLANT SITE. THE AFFECTED AREA WAS THOROUGHLY CLEANED AND THE IPP WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A TACTRA DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Purulent Discharge; Unspecified Infection
MAUDE report 25856053 ↗InjuryMar 31, 2026Collapse; Fluid/Blood Leak; Mechanical Problem; Migration; Air/Gas in Device
IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) MIGRATED. UPON REVISION, AIR WAS NOTED WITHIN THE PUMP, AND THE PUMP WOULD NOT REFILL WHEN CONNECTED TO THE RESERVOIR. THE PUMP WAS ALSO FOUND TO BE FLAT. THE RESERVOIR WAS FLAT AND EMPTY UPON REMOVAL. NO LEAKS IN THE SYSTEM WERE APPARENT WHEN EXAMINED AND TESTED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24737968 ↗InjuryFeb 26, 2026Inflation Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPERIENCING DIFFICULTY PUMPING THE DEVICE, AND THE PUMP WAS REPORTED TO NOT FILL PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453632 ↗InjuryFeb 24, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size; Migration
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED PUMP TUBING BUNCHING. DURING A SUBSEQUENT SURGICAL PROCEDURE, IT WAS DETERMINED THAT THE TUBING HAD BEEN INITIALLY TRIMMED TOO SHORT, CAUSING THE PUMP TO RIDE HIGH WITHIN THE PENOSCROTAL JUNCTION. THE PUMP WAS REPLACED WITH A NEW TENACIO PUMP TO PROVIDE ADEQUATE TUBING LENGTH AND ENSURE PROPER POSITIONING. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434579 ↗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 ↗InjuryDec 3, 2025Inflation Problem; Nonstandard Device; Inflation Problem; Nonstandard Device
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE BECAUSE IT WAS NOT FULLY INFLATING. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE SYSTEM WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23711219 ↗MalfunctionOct 30, 2025Deflation Problem; Inflation Problem; Failure to Deflate; Deflation Problem; Inflation Problem; Failure to Deflate
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY INFLATING AND DEFLATING THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425729 ↗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 ↗InjuryMay 6, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) IS UNABLE TO ACTIVATE THE DEVICE TO INFLATE IT, ALSO THE PATIENT IS HAVING DIFFICULTY ACTIVATING THE DEVICE DUE TO SEVERE PAIN. THE PATIENT IS CONCERNED ABOUT THE SITUATION AND HAS AN APPOINTMENT WITH THE PHYSICIAN TO DISCUSS NEXT STEPS. THERE IS NO ADDITIONAL INFORMATION REPORTED.
Patient problems: Pain
MAUDE report 21973284 ↗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 ↗InjuryApr 23, 2025Mechanical Problem; Malposition of Device; Mechanical Problem; Malposition of Device
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) DISCOMFORT ON THE SCROTUM. IT WAS NOTICED THAT THE PUMP WAS DIFFICULT TO CYCLE. THE PUMP RETRACTED BACK VERY HIGH AND DEEP IN THE SCROTUM; THE DEFLATION BUTTON WAS HARDER TO FIND. THE DEVICE IS STILL IMPLANTED. NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Discomfort; Pain
MAUDE report 21892017 ↗InjuryMar 3, 2025Deflation Problem; Defective Device; Deflation Problem; Defective Device
IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) WAS TOO HARD TO PUMP AND SOMETIMES, THE DEVICE AUTO DEFLATES. IT WAS ALSO REPORTED PATIENT EXPERIENCED PAIN. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM WITHOUT PATIENT COMPLICATIONS.
Patient problems: Pain
MAUDE report 21510230 ↗
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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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