KLAClass II

Monitor, Esophageal Motility, Anorectal Motility, And Tube

Gastroenterology, Urology · 21 CFR 876.1725

MDR events7All time

Recalls1All time

Registered firms18Currently listed

510(k) clearances31All time

Recent MDR events

7 adverse event reports on file

MCOMPASS ANORECTAL MANOMETRY CATHETERJun 10, 2024
MalfunctionMedspira, Llc19497471
MCOMPASS ANORECTAL MANOMETRY CATHETEROct 25, 2023
MalfunctionMedspira, Llc18002755
MCOMPASS ANORECTAL MANOMETRY CATHETEROct 10, 2023
MalfunctionMedspira, Llc17904707
LATITUDE CATHETERMay 22, 2020
MalfunctionUnisensor Ag10082540
ESOPHAGEAL MANOMETRY CATHETERAug 17, 2018
MalfunctionDiversatek Healthcare, Inc. / Sandhill Scientific, Inc.MW5079232
MCOMPASS ANORECTAL MANOMETRY SYSTEMMar 8, 2017
InjuryMedspiraMW5068364
WATER PERFUSION MANOMETRYJun 4, 2015
MalfunctionArndorferMW5043025

Event type breakdown

Malfunction6

Injury1

Most-reported manufacturers

Medspira, Llc3 Arndorfer1 Diversatek Healthcare, Inc. / Sandhill Scientific, Inc.1 Medspira1 Mms1 Unisensor Ag1

Recalls

1 recall events for this product code

Medtronic Gastroenterology / Urology
TerminatedJun 22, 2006
Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapoli
Mislabeling- 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 sequentially 1 through 8, from the distal to the proximal end of the catheter.
Z-1159-06 · View FDA record ↗

Registered firms

18 firms currently registered for this product code

510(k) clearances

31 clearances for this product code