FDA recall Z-3072-2017

Product

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.

Reason for recall

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.

Distribution

Worldwide Distribution - US Distribution to the states of :CA, FL, IA, ID, and TX., and to the countries of : Austria, Italy, Malaysia, Philippines, Sweden, and United Kingdom

Key facts

Status

Terminated

Initiation date

2017-06-14

Report date

2017-09-06

Termination date

2021-08-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3072-2017