FDAJune 14, 2017device
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a med...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.
What to do
FDA enforcement status: Terminated
Brands named
medspira
Recall history
No related federal recalls on record for this brand yet.
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