Z-3072-2017Class II

mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on...

Name: Z-3072-2017 mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on...
Creator: Medspira, Llc
Published: 2017-06-14
License: https://open.fda.gov/license/

Medspira, LLC / initiated 2017-06-14 / Terminated / root cause: manufacturing process

FDA source

Medspira, Llc began a recall of mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass... on 2017-06-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3072-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-14
Posted: 2017-08-25
Terminated: 2021-08-24
Recalling firm: Medspira, LLC
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.
Product code: GBT Catheter, Rectal
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 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
Product codes and lots: Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3072-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3072-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-25

Product code GBT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)