Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System Recalled by Medspira, Llc Due to Potential failure in the balloon bond in the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medspira, Llc directly.
Affected Products
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.
Quantity: 355 catheters (255 US - 100 foreign. )
Why Was This 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.
Where Was This Sold?
This product was distributed to 5 states: CA, FL, ID, IA, TX
About Medspira, Llc
Medspira, Llc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report