Reported Dec 2, 2020 · Terminated
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are…
Coloplast Manufacturing US, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Coloplast Manufacturing US, LLC · 1601 W River Rd · Minneapolis, MN · 55411-3431
Is this the product you have?
- Titan Pump - Product Usageindicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis
- Lot codes and dates
686 of 686 codes
558521556370615887656588766058876626044855612194862036966256289628181462820776293595634094963973216450370646792065231846563685656502566200806625337671321567415596741597675925167592526778965678163568284206891543689164769459026949447699334170233927050985705100671082097109949714999571500197150020718012171801227261757726376672637917289306729992173483627356189743367764088706563692694252469933517045704726176464088716563693
- Amount recalled
- 8,962 units
Where it was sold
Why it was recalled
Potential increased occurrence of pump fracture over the lifetime of the device.
This product could cause temporary or reversible health problems — stop using it.
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