Device recall: Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Class II FDA enforcement event 91800. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Coloplast Manufacturing US, LLC started this device recall on 1 Mar 2023. The firm address in the FDA record is in Minneapolis, MN. FDA put the recall in Class II. FDA event 91800 has 17 product records. The first FDA enforcement report date is 19 Apr 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Recalling firm
Coloplast Manufacturing US, LLC, Minneapolis, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
17 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1359-2023 | Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis | 18 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1360-2023 | Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis | 9 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1361-2023 | Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis | 0 | Class II | Ongoing | 19 Apr 2023 |
| Z-1362-2023 | Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis | 7 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1363-2023 | Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis | 2 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1364-2023 | Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis | 13 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1365-2023 | Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis | 2 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1366-2023 | Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis | 0 | Class II | Ongoing | 19 Apr 2023 |
| Z-1367-2023 | Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis | 15 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1368-2023 | Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis | 8 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1369-2023 | Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis | 1 unit | Class II | Ongoing | 19 Apr 2023 |
| Z-1370-2023 | Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis | 20 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1371-2023 | Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis | 11 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1372-2023 | Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis | 22 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1373-2023 | Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis | 25 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1374-2023 | Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis | 20 units | Class II | Ongoing | 19 Apr 2023 |
| Z-1375-2023 | Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis | 23 units | Class II | Ongoing | 19 Apr 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 17Median of the firm: 1
- Events of the firm on the register
- 11
Other events of the firm
Official channels
- FDA enforcement report Z-1359-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 91800. https://recallregister.com/fda/ii/91800/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
- What quantity of product is in FDA event 91800?
- The event has 17 product records. The first record gives this quantity:
18 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.