Recall Z-3072-2017— Medspira, Llc
Class II · Terminated
Class II FDA medical device recall by Medspira, Llc, initiated 2017-06-14, terminated 2021-08-24. It names 2 FDA 510(k) clearances: K143031, K120088. 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: 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..
- Recalling firm
- Medspira, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-14
- Terminated
- 2021-08-24
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K143031 — mcompass Biofeedback Anorectal Manometry System
- K120088 — MCOMPASS ANORECTAL MANOMETRY SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.