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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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