Devices › Device, impotence, mechanical/hydraulic
Device brand name · Device impotence mechanical/hydraulic
AMS Inflatable Penile Prosthesis: medical device reports filed with FDA
9,119 reports name it, 1996–2026. Manufacturer given most often on reports: Boston Scientific. Product code FHW.
- 9,119
- device reports naming the brand
- 0% of all MAUDE reports · about 299 a year
- 687
- reports, 12 months to August 2026
- 866 in the 12 months before
- 7.5%
- classified as malfunction
- 8.8% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
9,119 medical device reports received by FDA name the brand "AMS Inflatable Penile Prosthesis" (device impotence mechanical/hydraulic); the manufacturer given most often on reports is Boston Scientific; received from January 1996 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
687 reports arrived in the 12 months to August 2026, down 21% from 866 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (92.5%) and malfunction (7.5%); across all device, impotence, mechanical/hydraulic reports (product code FHW) death is recorded in 0% and malfunction in 8.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are mechanical problem (31.7%), fluid/blood leak (23%) and material puncture/hole (21.6%). The patient problems coded most often are pain, erosion and discomfort. FDA states that "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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 38,562 reports carrying product code FHW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Mechanical problema mechanical problem | 2,891 | 31.7% | 14.1% |
| Fluid/blood leak | 2,097 | 23% | 16.1% |
| Material puncture/hole | 1,967 | 21.6% | 8.8% |
| Inflation problem | 1,766 | 19.4% | 13.8% |
| Insufficient device problem information | 1,350 | 14.8% | 8.1% |
| Migrationthe device moved from where it was placed | 537 | 5.9% | 4.1% |
| Defective devicethe device was defective | 481 | 5.3% | 2.4% |
| Collapse | 452 | 5% | 2.2% |
| Deflation problem | 298 | 3.3% | 2.5% |
| Inadequacy of device shape and/or size | 285 | 3.1% | 3.5% |
| Malposition of device | 234 | 2.6% | 2% |
| Degraded | 219 | 2.4% | 1.3% |
| Breakthe device broke | 139 | 1.5% | 2.6% |
| Failure to cycle | 120 | 1.3% | 0.6% |
| Material deformation | 96 | 1.1% | 0.8% |
| Air/gas in device | 61 | 0.7% | 0.4% |
| Nonstandard device | 41 | 0.4% | 0.2% |
| Unintended deflation | 30 | 0.3% | 0.3% |
| Connection problema connection problem | 29 | 0.3% | 0.2% |
| Failure to deflate | 26 | 0.3% | 0.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 471 | 5.2% |
| Erosion | 382 | 4.2% |
| Discomfortdiscomfort | 228 | 2.5% |
| Perforation | 113 | 1.2% |
| Swelling/ edema | 55 | 0.6% |
| Capsular contracturescar tissue tightening around an implant | 53 | 0.6% |
| Complaint, ill-defined | 52 | 0.6% |
| Scar tissue | 51 | 0.6% |
| Adhesion(s) | 43 | 0.5% |
| Inflammationinflammation | 40 | 0.4% |
| Wound dehiscencea wound reopened | 34 | 0.4% |
| Deformity/ disfigurement | 30 | 0.3% |
| Hematomaa collection of blood under the skin or in tissue | 22 | 0.2% |
| Swellingswelling | 21 | 0.2% |
| Tissue damage | 21 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AMS Inflatable Penile Prosthesis | Product code FHW | All MAUDE reports |
|---|---|---|---|
| Reports | 9,119 | 38,562 | 26,136,888 |
| Share of that pool | — | 23.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 92.5% | 90.8% | 36.2% |
| Classified as malfunction | 7.5% | 8.8% | 62.3% |
| Filed by the manufacturer | 99.9% | 97.7% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FHW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| AMS Inflatable Penile Prosthesis with Inhibizone | 6,665 | 5 | 0% |
| Titan inflatable penile prosthesis family | 5,326 | 1,773 | 0% |
| Inflatable Penile Prosthesis | 3,491 | 8 | 0% |
| Titan Touch | 2,066 | 0 | 0% |
| Titan | 2,078 | 0 | 0% |
| Alpha I | 1,285 | 0 | 0% |
| AMS Ambicor Penile Prosthesis | 906 | 28 | 0% |
| Dynaflex Penile Prosthesis | 805 | 0 | 0% |
| Aphi | 717 | 0 | 0% |
| Titan Otr | 386 | 0 | 0% |
| Alpha I Inflatable Penile Prosthesis | 349 | 0 | 0% |
| Hydroflex Penile Prosthesis | 318 | 0 | 0% |
| Ambicor Penile Prosthesis | 314 | 0 | 0% |
| Titan Touch Scro Zero Ang 18cm | 184 | 0 | 0% |
| Surgitek Gel Mammary Implant | 369 | 0 | 0.5% |
Ordered by report count for navigation only. FDA states that "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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about AMS Inflatable Penile Prosthesis reports
How many FDA reports name AMS Inflatable Penile Prosthesis?
9,119 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 687 in the latest 12 months.
What kinds of events are reported?
injury (92.5%) and malfunction (7.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical problem (31.7%), fluid/blood leak (23%), material puncture/hole (21.6%), inflation problem (19.4%) and insufficient device problem information (14.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that AMS Inflatable Penile Prosthesis was at fault?
No. FDA states that "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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.