# P000006: Titan Inflatable Penile Prosthesis

- Pathway: PMA
- Applicant: Coloplast Corp.
- Decided: Jul 14, 2000 after 178 days
- Product code: FHW (Device, Impotence, Mechanical/Hydraulic)
- Device class: 3
- Regulation: 21 CFR 876.3350
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 1, 2023 · Class II · Z-1362-2023: 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 t
- Mar 1, 2023 · Class II · Z-1360-2023: 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 t
- Mar 1, 2023 · Class II · Z-1363-2023: 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 t
- Mar 1, 2023 · Class II · Z-1372-2023: 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 t
- Mar 1, 2023 · Class II · Z-1370-2023: 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 t
- Mar 1, 2023 · Class II · Z-1366-2023: 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 t
- Mar 1, 2023 · Class II · Z-1368-2023: 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 t
- Mar 1, 2023 · Class II · Z-1359-2023: 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 t
- Mar 1, 2023 · Class II · Z-1374-2023: XXX
- Mar 1, 2023 · Class II · Z-1375-2023: 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 t
- Mar 1, 2023 · Class II · Z-1365-2023: 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 t
- Mar 1, 2023 · Class II · Z-1364-2023: 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 t
- Mar 1, 2023 · Class II · Z-1371-2023: 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 t
- Mar 1, 2023 · Class II · Z-1367-2023: 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 t
- Mar 1, 2023 · Class II · Z-1369-2023: 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 t
- Mar 1, 2023 · Class II · Z-1373-2023: 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 t
- Mar 1, 2023 · Class II · Z-1361-2023: 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 t
- Oct 6, 2009 · Not classified · Z-0171-2010: 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 spec

Source page: https://510kreport.com/device/P000006
Methodology: https://510kreport.com/methodology