Titan inflatable penile prosthesis recalled due to premature pump failure risk
Coloplast is recalling the Titan 0-Deg inflatable penile prosthesis due to decreased pump wall thickness that may cause premature device failure. The recall affects 23 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a structural defect creating a potential risk of device failure. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling certain units of the Titan 0-Deg Scrotal 22 Cm inflatable penile prosthesis (Catalog Number ES89222400). The recall affects 23 units with the following lot numbers: 8849602, 8904182, 8840688, and 8849622.
The affected devices have decreased wall thickness in the pump mechanism. This defect creates a risk for premature pump failure during normal use, as repeated inflation and deflation cycles may cause the pump to fail prematurely compared to devices with standard wall thickness.
The recalled devices were distributed worldwide, including throughout the United States and in Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal.
Patients who have this device should contact their healthcare provider or Coloplast Manufacturing to determine whether their specific unit is affected by the recall.
The recalled product
- Product
- Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI 05708932487382
- Lot Numbers: 8849602
- 8904182
- 8840688
- 8849622
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Coloplast Manufacturing US, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
Same manufacturer · Coloplast Manufacturing US, LLC
See all →- HighFolysil Silicone Foley Catheters Recalled for Possible Sterility Issue
FDA (Devices) · 2025-01-22
- HighX-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect
FDA (Devices) · 2025-01-22
- HighColoplast Ureteral Dilators Recalled Due to Sterile Packaging Issue
FDA (Devices) · 2024-04-10
- HighInflatable Penile Prosthesis Risk of Premature Pump Failure
FDA (Devices) · 2023-04-19
- HighInflatable penile prosthesis recalled due to pump wall thickness manufacturing defect
FDA (Devices) · 2023-04-19
Same hazard · pump failure
See all →- SevereAutomated Impella Controller units recalled for pump performance risk
FDA (Devices) · 2025-10-01
- CriticalImpella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- SevereIvenix Infusion Pump Software Recalled for Potential Malfunctions
FDA (Devices) · 2024-10-02
- SevereCardiosave Rescue IABP Pumps Recalled for System Overheating and Pump Failure
FDA (Devices) · 2023-09-06
- SevereCardiosave Hybrid Intra-Aortic Balloon Pumps recalled for autofill failure
FDA (Devices) · 2023-09-06