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.
FDA Recall Z-3072-2017 · Posted None
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Recalling FirmMedspira, Llc
Recall StatusTerminated
Product CodeGBT
Date Initiated2017-06-14
Date Terminated2021-08-24
Product Quantity355 catheters (255 US - 100 foreign. )
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.
Firm Action
The firm Medspira plans to contact all foreign and domestic consignees in regards to the recall. International consignees are to destroy recalled product by cutting the catheter shaft and balloon with scissors. It is also requested that their own customers be notified of the recall. Medspira plans to provide product replacement. Domestic customers are asked to return affected catheters to the recalling firm. Medspira indicates that they will cove shipping costs and replacements. All consignees are asked to complete and return the attached recall response form. For further questions please call, (612) 789-0013.
Root Cause
Employee error
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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