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System, mcompass®, Anorectal Manometry

MEDSPIRA, LLC · Model RMD-201 · UDI-DI 00851607003457

KLA
10
510(k) clearances
7
Adverse events
1
Recalls
15
Facilities

Description

System, mcompass®, Anorectal Manometry

Recalls

DateFirmReason
2006-04-06Medtronic Gastroenterology / UrologyMislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.