Class II — Medspira, Llc
| Recalling firm | MEDSPIRA LLC |
|---|---|
| Registered facility | MEDSPIRA LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 355 catheters (255 US - 100 foreign. ) |
| Distribution | 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 |
| Initiated | 2017-06-14 |
| Classified | 2017-08-25 |
| Terminated | 2021-08-24 |
| Recall number | Z-3072-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medspira, Llc (Z-3072-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77706/
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