AMS 700 CX MS PumpRecalls & reported problems across all models
Boston Scientific Corporation · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,641
- Deaths reported
- 0
- Injuries reported
- 3,261
- Recalls
- 0
We found 24 models of AMS 700 CX MS Pump by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 3,641 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2018 and Sep 30, 2026 — classified as 3,261 injuries, 380 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (1,118 reports).
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
Most reported AMS 700 CX MS Pump problems
Device problems
- Mechanical Problem1,118
- Inflation Problem1,115
- Fluid/Blood Leak911
- Adverse Event Without Identified Device or Use Problem882
- Material Puncture/Hole617
- Migration267
- Insufficient Device Problem Information231
- Collapse219
Patient problems
- No Clinical Signs, Symptoms or Conditions1,865
- No Known Impact Or Consequence To Patient419
- Unspecified Infection380
- Pain284
- Erosion254
- No Consequences Or Impact To Patient200
- Discomfort159
- Insufficient Information103
AMS 700 CX MS Pump models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS 700 CX MS Pump 72404233-12Prosthesis, Penis, Inflatable656 reports
- AMS 700 CX MS Pump 72404232Prosthesis, Penis, Inflatable639 reports
- AMS 700 CX MS Pump 72404232-10Prosthesis, Penis, Inflatable533 reports
- AMS 700 CX MS Pump 72404231Prosthesis, Penis, Inflatable423 reports
- AMS 700 CX MS Pump 72404233Prosthesis, Penis, Inflatable342 reports
- AMS 700 CX MS Pump 72404238Prosthesis, Penis, Inflatable312 reports
- AMS 700 CX MS Pump 72404237Prosthesis, Penis, Inflatable262 reports
- AMS 700 CX MS Pump 72404234-14Prosthesis, Penis, Inflatable144 reports
- AMS 700 CX MS Pump 72404236Prosthesis, Penis, Inflatable90 reports
- AMS 700 CX MS Pump 72404282Prosthesis, Penis, Inflatable53 reports
- AMS 700 CX MS Pump 72404239Prosthesis, Penis, Inflatable49 reports
- AMS 700 CX MS Pump 72404281Prosthesis, Penis, Inflatable32 reports
- AMS 700 CX MS Pump 72404230Prosthesis, Penis, Inflatable30 reports
- AMS 700 CX MS Pump 72404283Prosthesis, Penis, Inflatable20 reports
- AMS 700 CX MS Pump 72404234Prosthesis, Penis, Inflatable17 reports
- AMS 700 CX MS Pump 72404235Prosthesis, Penis, Inflatable15 reports
- AMS 700 CX MS Pump 72404280Prosthesis, Penis, Inflatable6 reports
- AMS 700 CX MS Pump 72404287Prosthesis, Penis, Inflatable5 reports
- AMS 700 CX MS Pump 72404283-12Prosthesis, Penis, Inflatable4 reports
- AMS 700 CX MS Pump 72404288Prosthesis, Penis, Inflatable3 reports
- AMS 700 CX MS Pump 72404286Prosthesis, Penis, Inflatable2 reports
- AMS 700 CX MS Pump 72404282-10Prosthesis, Penis, Inflatable2 reports
- AMS 700 CX MS Pump 72404289Prosthesis, Penis, Inflatable1 report
- AMS 700 CX MS Pump 72404284-14Prosthesis, Penis, Inflatable1 report
Recent AMS 700 CX MS 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, 2026Human-Device Interface Problem
Patient problems: Swelling/ Edema
MAUDE report 50954695 ↗InjurySep 30, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947387 ↗InjurySep 29, 2026Fluid/Blood Leak; Inflation Problem; Material Deformation; Migration; Air/Gas in Device
It was reported that this patient with an Inflatable Penile Prosthesis (IPP) came into a postoperative visit two weeks later with a hematoma, swelling, and the pump was displaced posteriorly. Two months post implant surgery the swelling had subsided. The patient returned to the clinic on (b)(6) 2026, and they could not inflate the cylinders by themselves, and they had discomfort in the perineum. A surgical procedure was performed. During the surgery, the physician noted the tubing was twisted and folded/retracted on itself on the right proximal top of the perineum, and there was a air and a leak in the system. No additional information was provided.
Patient problems: Discomfort; Hematoma; Swelling/ Edema
MAUDE report 50936905 ↗InjurySep 29, 2026Migration
It was reported that the cylinders of an Inflatable Penile Prosthesis (IPP) herniated into the patient's scrotum and outside the corpora. The patient does not know how it happened. A surgical procedure was performed to remove and replace the IPP. No further patient complications were reported.
Patient problems: Unspecified Tissue Injury
MAUDE report 50933129 ↗InjurySep 28, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915999 ↗InjurySep 28, 2026Inflation Problem; Material Puncture/Hole; Air/Gas in Device
It was reported that this Inflatable Penile Prosthesis (IPP) presented inflation issues. Upon revision, physician observed that tubing was fractured on the right cylinder at the junction of tubing and the pump. Additional information received states that air was present in the pump. A surgical procedure was performed during which the existing device was explanted and replaced. There were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915104 ↗InjurySep 25, 2026Deflation Problem
Patient problems: Capsular Contracture
MAUDE report 50903841 ↗InjurySep 25, 2026Collapse; Inflation Problem; Mechanical Problem; Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898460 ↗InjurySep 25, 2026Collapse; Inflation Problem; Material Puncture/Hole; Use of Device Problem; Air/Gas in Device
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) could not inflate his device. During revision surgery, a flat pump, the presence of air within the pump, a hole in the cylinder, and inflation difficulties were identified. The patient stated that he may have forcefully compressed both the inflation and deflation buttons simultaneously and believed this may have damaged the pump. The physician considered the event to be related to user operation. As a result, the cylinders and pump were explanted and replaced. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893257 ↗InjurySep 24, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891979 ↗InjurySep 23, 2026Migration
Patient problems: Pain; Unspecified Tissue Injury
MAUDE report 50874851 ↗MalfunctionSep 23, 2026Deflation Problem; Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872606 ↗InjurySep 23, 2026Insufficient Device Problem Information
It was reported that, during this Inflatable Penile Prosthesis (IPP) implant procedure, a urethral injury occurred; therefore, a Tactra device was implanted instead. Some time later, the malleable device was removed and replaced with the intended IPP. No further patient complications were reported.
Patient problems: Perforation
MAUDE report 50870131 ↗InjurySep 23, 2026Inflation Problem
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) developed a hematoma following the original implantation procedure. The resulting scrotal swelling prevented the patient from effectively operating the device and locating the deflation button. As a result, the pump was explanted and repositioned within the scrotum to facilitate easier use. No further patient complications were reported.
Patient problems: Hematoma; Swelling/ Edema
MAUDE report 50869029 ↗InjurySep 22, 2026Inflation Problem; Material Puncture/Hole
It was reported that this Inflatable Penile Prothesis (IPP)'s pump wasn't working properly, it stayed flat and would not inflate. Upon revision, a hole in right cylinder was noticed. As a result, the device was explanted and replaced. No further patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855055 ↗
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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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