Inflatable penile prosthesis recalled due to pump wall thickness manufacturing defect
Coloplast is recalling Titan NB inflatable penile prostheses with reduced pump wall thickness that may cause premature pump failure during normal use.
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 medical device recall for a manufacturing defect (decreased pump wall thickness) that creates potential for device failure. This is a risk-of-harm product where no illnesses or injuries have been reported, placing it at the maximum score of 3 per the rubric.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling Titan NB Scrotal Zero Ang 18cm inflatable penile prostheses (Catalog Number EN88182400, UDI/DI 05708932072649, Lot Numbers 8887622 and 8965351) due to a manufacturing defect in the pump component.
The recalled devices have decreased wall thickness in the pump compared to devices with standard wall thickness. This defect has the potential for premature pump failure based on the number of interactions required to inflate and deflate the prosthesis during normal use.
The affected devices were distributed worldwide, including throughout the United States and in Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal.
The recalled product
- Product
- Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
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 (3)
- UDI/DI 05708932072649
- Lot Numbers: 8887622
- 8965351
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 Prosthesis Pump Assembly Recalled for Premature Failure Risk
FDA (Devices) · 2023-04-19
- HighInflatable Penile Prosthesis Recalled for Potential Pump Failure Risk
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