CLASS II ONGOING Device recall · Reported 19 Apr 2023 · FDA Enforcement Report
Titan 0-Deg Infrapubic recalled by Coloplast Manufacturing US
Coloplast Manufacturing US is recalling Titan 0-Deg Infrapubic, distributed nationwide in the US. The recall was initiated on 1 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1372-2023
- FDA event ID
- 91800
- Recalling firm
- Coloplast Manufacturing US, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2023
- FDA classified
- 12 Apr 2023
- Reported
- 19 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Mar 2023 | Recall initiated by company | |
| 12 Apr 2023 | Classified by FDA | +42 days |
| 19 Apr 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 05708932487245, Lot Numbers: 8849577, 8849578
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 91800This product is part of a recall event; the main page for the event is Titan Pump Assembly recalled by Coloplast Manufacturing US.
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