Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 6, 2017
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medspira, Llc recalled mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry Syst… - a moderate-severity action.
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry Syst… was recalled by Medspira, Llc in September 6, 2017. Reason: Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon fr…. Check the official notice for the remedy. Verify recall #Z-3072-2017 with the FDA Devices before acting.
The recall
Medspira, Llc issued this moderate-severity FDA Devices recall-Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon fr….
- Moderate
- severity level
- Class II
- classification
- September 6, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3072-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3072-2017) was formally reported on September 6, 2017, with the manufacturer initiating the action on June 14, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medspira, Llc is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 355 catheters (255 US - 100 foreign. ).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
355 catheters (255 US - 100 foreign. )
Related Recalls
6
0 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3072-2017 |
| Date reported | September 6, 2017 |
| Date initiated | June 14, 2017 |
| Recalling firm | Medspira, Llc |
| Firm location | Minneapolis, MN |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3072-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medspira, Llc. Units affected: 355 catheters (255 US - 100 foreign. ).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2017. Severity: Moderate. Recall number: Z-3072-2017.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3072-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 6, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.