Medspira, Llc: Medical Device Recall in 2017 - (Recall #: Z-3072-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 14, 2017

Date Posted: September 6, 2017

Recall Number: Z-3072-2017

Event ID: 77706

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.

Status: Terminated

Product Quantity: 355 catheters (255 US - 100 foreign. )

Code Information:

Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated