Device 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.
Z-3072-2017
Product summary
- Firm
- Medspira, Llc
- Event
- Event 77706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 355 catheters (255 US - 100 foreign. )
- Official record key
device-enforcement:Z-3072-2017
Official wording
Reason: 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.
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
Derived failure modes
-
Unknown
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.