Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
FDA device recall Z-1359-2023 · posted 2023-04-12 · Open, Classified
Recall details
- Recalling firm
- Coloplast Manufacturing US, LLC
- Reason for recall
- 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.
- Action taken
- The firm issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice on 03/01/2023 by UPS next day air. The notice explained the issue and the hazard to health. The notice requests the removal and return of the affected product. Distributors are instructed to notify their customers. For further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email urology@coloplast.com.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- FHW
- Quantity affected
- 18 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
- Date initiated
- 2023-03-01
- Date posted
- 2023-04-12
- Location
- Minneapolis, MN
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