mcompass 2-channel Balloon Catheters The mcompass Biofeedback… — Class II medical device recall Z-3072-2017
Terminated recall by Medspira, Llc, reported 2017-09-06, distributed in CA, FL, IA, ID, TX. Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon fro
| Recall number | Z-3072-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medspira, Llc, Minneapolis, MN, United States |
| Recall initiated | 2017-06-14 |
| Classified | 2017-08-25 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2021-08-24 |
| Distributed | CA, FL, IA, ID, TX |
| Countries outside the US | AT, GB, IT, MY, PH, SE |
| Lot numbers | 160627-10, 160627-11 |
| Model numbers | RMD-002-004 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3072-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.