AMS 700 CX TENACIO PumpRecalls & reported problems across all models
Boston Scientific Corporation · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one AMS 700 CX TENACIO Pump model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 251
- Deaths reported
- 0
- Injuries reported
- 231
- Recalls
- 2
We found 12 models of AMS 700 CX TENACIO Pump by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 251 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2024 and Sep 28, 2026 — classified as 231 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (112 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 CX 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-0142-2026 · Root cause: Nonconforming Material/Component · names 10 of these models · Recall details · FDA record ↗
- Sep 11, 2025Open, Classified
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Z-0140-2026 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
Most reported AMS 700 CX TENACIO Pump problems
Device problems
- Inflation Problem112
- Adverse Event Without Identified Device or Use Problem57
- Mechanical Problem45
- Migration34
- Fluid/Blood Leak21
- Malposition of Device19
- Deflation Problem14
- Material Puncture/Hole14
Patient problems
- No Clinical Signs, Symptoms or Conditions132
- Pain44
- Unspecified Infection39
- Discomfort26
- Erosion17
- Swelling/ Edema16
- Unspecified Tissue Injury11
- Hematoma7
AMS 700 CX TENACIO Pump models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS 700™ CX TENACIO™ Pump 72404433Prosthesis, penis, inflatable1 recall101 reports
- AMS 700™ CX TENACIO™ Pump 72404432Prosthesis, penis, inflatable1 recall64 reports
- AMS 700™ CX TENACIO™ Pump 72404438Prosthesis, penis, inflatable1 recall28 reports
- AMS 700™ CX TENACIO™ Pump 72404434Prosthesis, penis, inflatable1 recall20 reports
- AMS 700™ CX TENACIO™ Pump 72404431Prosthesis, penis, inflatable1 recall12 reports
- AMS 700™ CX TENACIO™ Pump 72404437Prosthesis, penis, inflatable1 recall12 reports
- AMS 700™ CX TENACIO™ Pump 72404439Prosthesis, penis, inflatable1 recall12 reports
- AMS 700™ CX TENACIO™ Pump 72404436Prosthesis, penis, inflatable1 recall2 reports
- AMS 700™ CX TENACIO™ Pump 72404430Prosthesis, penis, inflatable1 recall0 reports
- AMS 700™ CX TENACIO™ Pump 72404435Prosthesis, penis, inflatable1 recall0 reports
- AMS 700™ CX TENACIO™ Pump 72404486Prosthesis, penis, inflatable1 recall0 reports
- AMS 700™ CX TENACIO™ Pump 72404488Prosthesis, penis, inflatable1 recall0 reports
Recent AMS 700 CX TENACIO Pump adverse event reports
The 15 most recent reports across all models, 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 25, 2026Deflation Problem; Inflation Problem; Unintended Deflation
It was reported that the patient with this Inflatable Penile Prosthesis (IPP), experienced difficulty operating the device. The patient reported that the deflation button would stick and would not release when pressed. The patient also reported episodes of auto inflation during sleep and stated that the device auto deflated during attempted use. Additionally, the patient indicated that repeated pumping did not appear to fully inflate the cylinders. Upon inspection, reservoir appeared to be scarred in vivo. As a result, the device was explanted and replaced. No further patient complications were reported.
Patient problems: Adhesion(s)
MAUDE report 50900285 ↗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 23, 2026Malposition of Device
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) stated the pump was positioned too posteriorly within the scrotum and could not be accessed. As a result, the device was explanted. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873895 ↗InjurySep 23, 2026Inflation Problem; Migration
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with a device that would not provide sufficient rigidity on one side and would not fully inflate on both sides. A revision surgery was performed, during which the physician confirmed that the right cylinder had migrated proximally within the corpora. The device was explanted and replaced. There were no further patient complications.
Patient problems: Unspecified Tissue Injury
MAUDE report 50869613 ↗InjurySep 23, 2026Collapse; Inflation Problem
It was reported that the patient with an Inflatable Penile Prosthesis (IPP) experienced device auto-inflation and difficulty inflating the device since the initial implant procedure. The auto-inflation was reportedly observed during office evaluations, and the pump was described as feeling gummy during use. A revision procedure was performed during which the Tenacio pump was explanted and replaced with an MS pump. No further patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867420 ↗InjurySep 21, 2026Mechanical Problem; Migration
Patient problems: Deformity/ Disfigurement; Impaired Healing; Numbness; Pain
MAUDE report 50847392 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) had a scrotal trauma at the pump location and now reports pain, with bacterial growth present around the testicular area. A surgical procedure was performed to remove the IPP. No device issues were reported. No additional patient complications were reported.
Patient problems: Bacterial Infection; Pain
MAUDE report 50847255 ↗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 7, 2026Mechanical Problem; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50651165 ↗InjurySep 2, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568977 ↗InjurySep 1, 2026Degraded; Inflation Problem; Infusion or Flow Problem; Migration
It was reported that the Inflatable Penis Prosthesis (IPP) started to bulge at the left cylinder corporal site about four months after implantation. Patient then had unrelated abdominal procedures in which the reservoir may have been displaced. As a result, the device was removed and replaced with a Tactra per Dr. request. No further patient complications were reported.
Patient problems: Discomfort
MAUDE report 50553497 ↗
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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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