AMS 700 LGX TENACIO PumpRecalls & reported problems across all models
Boston Scientific Corporation · 10 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 LGX TENACIO Pump model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 97
- Deaths reported
- 1
- Injuries reported
- 88
- Recalls
- 2
We found 10 models of AMS 700 LGX TENACIO Pump by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Sep 16, 2024 and Sep 30, 2026 — classified as 1 death, 88 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (34 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 LGX 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-0144-2026 · Root cause: Nonconforming Material/Component · names 8 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-0141-2026 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
Most reported AMS 700 LGX TENACIO Pump problems
Device problems
- Inflation Problem34
- Adverse Event Without Identified Device or Use Problem29
- Mechanical Problem21
- Migration17
- Unintended Deflation11
- Fluid/Blood Leak10
- Inadequacy of Device Shape and/or Size8
- Material Puncture/Hole8
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Pain25
- Unspecified Infection14
- Discomfort12
- Swelling/ Edema10
- Erosion7
- Deformity/ Disfigurement3
- Erythema3
AMS 700 LGX TENACIO Pump models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS 700 LGX™ TENACIO™ Pump 72404452Prosthesis, penis, inflatable1 recall1 death39 reports
- AMS 700 LGX™ TENACIO™ Pump 72404451Prosthesis, penis, inflatable1 recall17 reports
- AMS 700 LGX™ TENACIO™ Pump 72404457Prosthesis, penis, inflatable1 recall17 reports
- AMS 700 LGX™ TENACIO™ Pump 72404456Prosthesis, penis, inflatable1 recall11 reports
- AMS 700 LGX™ TENACIO™ Pump 72404453Prosthesis, penis, inflatable1 recall6 reports
- AMS 700 LGX™ TENACIO™ Pump 72404458Prosthesis, penis, inflatable1 recall6 reports
- AMS 700 LGX™ TENACIO™ Pump 72404455Prosthesis, penis, inflatable1 recall1 report
- AMS 700 LGX™ TENACIO™ Pump 72404405Prosthesis, penis, inflatable1 recall0 reports
- AMS 700 LGX™ TENACIO™ Pump 72404407Prosthesis, penis, inflatable1 recall0 reports
- AMS 700 LGX™ TENACIO™ Pump 72404450Prosthesis, penis, inflatable1 recall0 reports
Recent AMS 700 LGX 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 30, 2026Inflation Problem; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953788 ↗InjurySep 29, 2026Malposition of Device
It was reported that this Inflatable Penile Prosthesis (IPP) was working but that since it was implanted the pump was riding high. During a clinic visit, the physician attempted to pull down the pump but reported that it seemed as good as it was going to get and that as long as it was working it was not a problem. More recently however, the pump seemed to be even higher to the point where the tubing was now rubbing on their pubic bone. When the patient is sitting, they have pain in their pelvic area, and they also reported that their penis is curved. The patient had Peyronies Disease and always had a slight curvature. However, they had the curvature fixed at the same time as their IPP implant surgery. The patient explained that the right cylinder was shorter than the left and was causing the penis to lean to the left. Per the patient it felt like the right cylinder was pushing outward through the side. The patient also saw their nurse practitioner (NP) who assessed it and was concerned about erosion of the cylinder over time because the skin on the side was very thin, but they were not an IPP specialist. The NP ordered a computed axial tomography (CAT) scan for (b)(6) 2026, to asse
Patient problems: Deformity/ Disfigurement; Erosion; Pain
MAUDE report 50937304 ↗InjurySep 25, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903844 ↗InjurySep 22, 2026Inadequacy of Device Shape and/or Size; Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860448 ↗InjurySep 22, 2026Inflation Problem; Mechanical Problem; Nonstandard Device
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with difficulty inflating the device, unable to easily cycle the device, and described as being hard to squeeze with slow deflation. The patient reported needed to pump the device multiple times with minimal inflation achieved. During physician consultation, the physician confirmed that the device was not inflating as intended. The patient was guided on proper pumping technique, including anchoring and holding the pump by tubing and squeezing from the bottom of the bulb to obtain more effective compressions. A surgical procedure was performed during which the pump was explanted and replaced. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857745 ↗InjurySep 10, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722320 ↗InjurySep 7, 2026Mechanical Problem; Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650905 ↗InjurySep 4, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size; Human-Device Interface Problem
It was reported that this Inflatable Penile Prosthesis (IPP) had difficulty cycling. A surgical procedure was performed during which the device was explanted and replaced. Upon explant the physician identified that the IPP was oversized. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50602296 ↗InjurySep 3, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576881 ↗InjuryAug 18, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) felt a pop. The device exhibited fluid loss. A surgical procedure was performed, during which a hole in the tubing extending from the pump to one of the cylinders was identified. As a result, the device was removed. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306571 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced pain. A surgical procedure was performed during which the IPP was removed and replaced with a malleable device. No additional patient complications were reported.
Patient problems: Pain
MAUDE report 50152101 ↗InjuryJul 29, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) was unable to inflate the device. The pump remained compressed and flat due to fluid loss caused by a break in the pump connecting tubing. A surgical procedure was performed, during which the IPP was removed and replaced with a Tactra malleable device at the patient's request due to manual dexterity issues. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070023 ↗InjuryJul 27, 2026Inflation Problem
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with auto inflation and dissatisfaction with the pump location. 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 50038238 ↗InjuryJul 20, 2026Inadequacy of Device Shape and/or Size; Malposition of Device
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced discomfort. The device was noted to be improperly positioned and oversized. As a result, the cylinders and pump were explanted and replaced with a smaller size, while the reservoir was retained. No further patient complications were reported.
Patient problems: Discomfort
MAUDE report 25876863 ↗InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced pump erosion through scrotal incision. As a result, the device was explanted and replaced with malleable. No further patient complications were reported.
Patient problems: Erosion; Wound Dehiscence
MAUDE report 25786451 ↗
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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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