Z-3072-2017 Class II Terminated
FDA device recall Z-3072-2017 was initiated by Medspira, Llc on Jun 14, 2017 and is designated Class II. 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. The recall status is terminated (terminated Aug 24, 2021). Affected quantity: 355 catheters (255 US - 100 foreign. ).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 6, 2017
- Initiation Date
- Jun 14, 2017
- Termination Date
- Aug 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 355 catheters (255 US - 100 foreign. )
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.
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 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
Code Information
Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.