Reported Sep 6, 2017 · Terminated
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients…
Medspira, 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: Medspira, Llc · 2718 Summer St NE · Minneapolis, MN · 55413-2820
Is this the product you have?
- 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 medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.
- Lot codes and dates
- Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.
- Amount recalled
- 355 catheters (255 US - 100 foreign. )
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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