Inflatable Prosthesis Pump Assembly Recalled for Premature Failure Risk
Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased 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: This is a risk-of-harm product (structural defect in an implanted medical device that could result in device failure) where no injuries or malfunctions have been reported. The hazard is theoretical based on potential failure from repeated use, meeting the criterion for Score 3.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling 9 Titan Pump Assemblies (Catalog Number 5177701400) used in inflatable penile prostheses. The recall involves Lot Numbers 8904177 and 8849617.
The affected pump assemblies have decreased wall thickness that has the potential to cause premature pump failure compared to pumps with standard wall thickness. The potential for failure depends on the number of times the device is inflated and deflated.
These units were distributed worldwide to the United States and to Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal.
If you have received one of these prostheses, contact Coloplast Manufacturing US, LLC or your healthcare provider immediately regarding replacement options and what actions you should take.
The recalled product
- Product
- Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Affected units
- 9
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 05708932319621
- Lot Numbers: 8904177
- 8849617
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 Rescue Intra-Aortic Balloon Pumps Recalled Due to Autofill Failure
FDA (Devices) · 2023-09-06