Coloplast Titan Pump Recall for Potential Device Fracture
Coloplast is recalling 8,962 Titan Pump units due to a potential increased occurrence of pump fracture over the device's lifetime.
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: The recall is classified as FDA Class II, and the hazard involves a structural defect (pump fracture) in an implanted medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling 8,962 units of the Titan Pump, a medical device indicated for male patients suffering from erectile dysfunction who are candidates for implantation of a penile prosthesis. The recall is being conducted due to a potential increased occurrence of pump fracture over the lifetime of the device.
The affected units were distributed worldwide, including nationwide distribution in the United States and in Denmark, Spain, and Japan. The source text does not specify reported illnesses, injuries, or fatalities associated with this defect.
Consumers and healthcare providers with this device should contact Coloplast Manufacturing US, LLC for instructions on how to proceed with the recall.
The recalled product
- Product
- Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- Affected units
- 8,962
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 (20)
- 5585215
- 5637061
- 5887656
- 5887660
- 5887662
- 6044855
- 6121948
- 6203696
- 6256289
- 6281814
- 6282077
- 6293595
- 6340949
- 6397321
- 6450370
- 6467920
- 6523184
- 6563685
- 6565025
- 6620080
Distribution
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 · device fracture
See all →- HighSurgify Halo surgical burr recalled for potential breakage during spinal surgery
FDA (Devices) · 2026-07-01
- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- SevereBeacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
- HighVASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System C-Ring Break
FDA (Devices) · 2025-04-30
- HighStryker ACM Bone Cement Mixer Nozzle May Break During Surgery
FDA (Devices) · 2023-09-27