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.
Enforcement
- Recall Number
- Z-3072-2017
- Event ID
- 77706
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medspira, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 6, 2017
- Initiation Date
- June 14, 2017
- Classification Date
- August 25, 2017
- Termination Date
- August 24, 2021
- Address
- 2718 Summer St NE, N/A, Minneapolis, MN, 55413-2820, United States
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.
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.
Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.
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
355 catheters (255 US - 100 foreign. )