Device: AMS 700 (Boston Scientific inflatable penile prosthesis) | Period: July 2026 | Pulled: 2026-08-06
Total reports: 171 (Jul 1 – Jul 31, 2026)
Lifespan & Age at Mechanical Malfunction: Summary statistics
N: 79 / 171 (mechanical, dated)
Median: 5 yrs
Mean: 5 yrs
Max: 12 yrs
Median patient age: 69 (n = 69 of 79 with age reported)
Percent distribution
- ≤ 1 yr: 16.5%
- >1–4 yrs: 27.8%
- 5–10 yrs: 54.4% ← highest concentration
- 11–15 yrs: 1.3%
Summary of Events: All 171 reports
- Infection: 7 of 171 reports (4.1%)
- Three give some clinical detail: one where the surgeon found purulent material in the scrotum during a procedure prompted by scrotal pain, confirming infection at the implant site; one presenting first as postoperative pain, with infection identified at follow-up and debridement performed before the revision; and one presenting as pain on activation, with infection confirmed at revision surgery.
- One report describes erosion and infection together, with the device found to have eroded distally through the urethra and the infection confirmed during the same procedure.
- The remaining three record the infection and the explant with no organism or symptom detail. Where a replacement was fitted it was most often a malleable device. Several of these reports note that infection is an acknowledged risk in the instructions for use rather than a device performance problem.
- Malfunction: 93 of 171 reports (54.4%), the largest category
- Leakage is the largest subcategory (25 reports): fluid loss, an empty reservoir found on imaging or at revision, or a leak the surgeon could not localise. A CT scan confirming an empty reservoir appears in several narratives as the step that established the diagnosis before surgery.
- Tubing Fracture accounts for 14 reports. A recurring pattern, appearing in five separately-reported cases with near-identical wording, is a patient presenting with the device not working and a crack found in the pump connecting tube at a procedure roughly two weeks later.
- Pump Failure accounts for 13 reports: pumps that had collapsed and stayed flat, pumps too hard to compress, one confirmed by ultrasound to have adequate fluid so that the pump itself was the suspected component, and one requiring excessive force that troubleshooting and training could not resolve.
- A further 13 reports state only that the device was non-functioning, would not cycle, or had lost functional efficacy, with no component identified; these are grouped as unspecified/other mechanical.
- Material Puncture (10 reports) covers holes found in reservoirs, in tubing near the pump, and at the junction of pump tubing and kink-resistant tubing. Cylinder Failure (9 reports) covers cylinder ruptures, tears in one or both cylinders, a torn outer sheath, and one cylinder whose inner silicone and mesh layers had burst.
- Failure to Deflate accounts for 4 reports, including one device left inflated for over a week. Two intraoperative failures were caught during implantation and the devices were never used: one that could not be deflated without continuously holding the release button, and one that inflated poorly and would not deflate after roughly ten test cycles. Two reports identify a tubing kink, and one records a device returned with no complaint attached whose laboratory analysis found cylinder wear, pump tubing worn from rubbing against itself, and a pump that passed leakage testing but failed functional activation, concluded as component failure on analysis.
- Full breakdown by cause (93 total): Leakage (25); Tubing Fracture (14); Pump Failure (13); unspecified/other mechanical (13); Material Puncture (10); Cylinder Failure (9); Failure to Deflate (4); Intraoperative (2); Tubing kink (2); component failure on analysis (1).
- Malposition: 31 of 171 reports (18.1%)
- Migration is the largest subgroup (7 reports), almost all reservoirs that had moved out of the space of Retzius and presented as a bulge in the lower abdomen, groin or scrotum; one was explicitly noted as not properly secured, and one was attributed to heavy lifting. Reservoir Herniation accounts for a further 3 reports.
- Erosion, confirmed rather than impending, accounts for 6 reports: cylinders eroding through the glans or the urethra, a pump eroding through a scrotal incision, and one cylinder found sitting outside the corpora cavernosa. One further report describes impending distal erosion caught before it broke through.
- Pump migration (3 reports) covers pumps riding high in the scrotum with excess or superficial tubing, one of which the patient could not operate past half inflation. One pump had adhered to the testicle, leaving the patient unable to compress it.
- Crossover accounts for 3 reports, one presenting as a device that would not hold rigidity with both cylinders found in the same corporal body, and one detected from a slight curvature in an otherwise properly functioning device. Floppy glans accounts for 3 reports, in each case with the cylinders not reaching the tip of the glans.
- Two reports describe aneurysms: a right-sided corporal aneurysm found when the device would not inflate, and a rupture of the tunical layer that produced a bulge in the cylinders. One describes a cylinder migrating out of the corporotomy into the scrotum, and one a reservoir compressing the femoral nerve, grouped as general positioning.
- Full breakdown by cause (31 total): Migration (7); Erosion, confirmed (6); Crossover (3); Floppy glans (3); Pump migration (3); Reservoir Herniation (3); Aneurysms (2); Cylinder migration (1); general positioning (1); Impending erosion (1); Pump stuck to the skin (1).
- Patient Dissatisfaction: 7 of 171 reports (4.1%)
- Size accounts for 5 reports: an oversized left cylinder causing pain, a device both oversized and improperly positioned that was replaced with a smaller one, an attenuated tunica with the cylinder downsized, an implant the physician judged oversized, and one patient who complained of the length and could feel the tubing.
- One cosmetic report describes curvature causing dissatisfaction, with the narrative noting that the device cycled properly and no device-related issue was present.
- One rigidity report is a physician account of explanting most of a patient's device for low satisfaction, citing poor performance and inadequate rigidity, with no component identified and the cause not established.
- Full breakdown by cause (7 total): Size (5); Cosmetic (1); Rigidity (1).
- Other / Unclear: 33 of 171 reports (19.3%)
- Nineteen reports had no narrative text published at the time of this pull. The record exists and carries a product-problem code, but FDA had not yet posted the event description, so no cause can be read from them. They are counted here rather than assigned to a cause on the strength of a code alone.
- Five describe a clinical complication with no device fault: glans necrosis in a patient noted as predisposed through compromised blood flow, an inflammatory reaction concluded as related to patient condition, pain and irritation traced to a capsule around the pump tubing, scrotal pain and discomfort, and pain alone.
- Four record no device fault identified despite a revision: a possible tubing kink where the pump then worked normally in theatre, difficulty using a pump with no cause stated, a device that inflated laterally rather than lengthways and was found fully functional once a large volume of tissue was removed, and one where the physician stated the pump was working and that protruding tubing is seen in some patients.
- Four describe a surgical or iatrogenic cause: a cylinder punctured by a suture needle while closing, a urethra perforated during an attempted implant, a pump obscured by capsule and hematoma, and a pump riding high after its tubing was cut too short at the original implant.
- One is a physician's blanket statement that all devices of one pump type implanted in their patients were revised for device issues, with no per-patient detail to classify.
- Full breakdown by cause (33 total): narrative not published (19); clinical complication (5); no device fault identified (4); surgical or iatrogenic (4); insufficient detail (1).
Data Source
FDA's public MAUDE database
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. The incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information. Submission of a medical device report and the FDA's release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.
