PMA · Approved
Recalled · Class II · 2023Titan Inflatable Penile Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · FHW Device, Impotence, Mechanical/Hydraulic
Approved on Jul 14, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 178-day review. It has been recalled 18 times.
- Decided
- Jul 14, 2000
- Review
- 178 days
- Class
- Class III
- Product code
- FHW
- Recalls
- 18
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P000006 has 69 supplements since 2002: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 6 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 5 |
| 2012 | 2 |
| 2013 | 5 |
| 2014 | 5 |
| 2015 | 7 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 4 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 4 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FHW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2023 | Class II | Z-1362-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1360-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1363-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1372-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1370-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1366-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1368-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1359-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1374-2023 | Process change control | XXX |
| Mar 1, 2023 | Class II | Z-1375-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1365-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1364-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1371-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1367-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1369-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1373-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Mar 1, 2023 | Class II | Z-1361-2023 | Process change control | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. |
| Oct 6, 2009 | Not classified | Z-0171-2010 | Process control | Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all… |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FHW devicesFHW Device, Impotence, Mechanical/Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FHW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FHW
Too few FHW 510(k)s in any year since 2007 to give a median.
Recalls per year · FHW
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FHW
2,537in 2025
MAUDE reports naming product code FHW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 11 |
| 2008 | 6 | — | 0 | 16 |
| 2009 | 2 | — | 1 | 15 |
| 2010 | 4 | — | 0 | 14 |
| 2011 | 5 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 5 | — | 0 | 19 |
| 2014 | 5 | — | 0 | 27 |
| 2015 | 10 | — | 0 | 9 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 2 | — | 0 | 512 |
| 2018 | 2 | — | 0 | 1,677 |
| 2019 | 3 | — | 0 | 4,010 |
| 2020 | 4 | — | 1 | 3,561 |
| 2021 | 2 | — | 1 | 3,715 |
| 2022 | 3 | — | 0 | 3,202 |
| 2023 | 3 | — | 0 | 3,673 |
| 2024 | 3 | — | 0 | 4,076 |
| 2025 | 2 | — | 0 | 2,537 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P000006 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000006: Titan Inflatable Penile Prosthesis.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000006
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026