Medspira mcompass Balloon Catheters Recall: Balloon May Separate in Rectum
Medspira recalls specific mcompass 2-channel balloon catheters due to risk of balloon separation in rectum. Affected units have part numbers RMD-002-004 and lots 160627-10/11. Contact for remedy.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Medspira is recalling certain mcompass 2-channel balloon catheters because the balloon could separate from the inner stem, leaving it in the rectum. This poses a risk of injury during medical procedures. Read more at govinfonow.com/recall/73870-medspira-mcompass-balloon-catheters-recall-balloon-may-separate-in-rectum.
Source Summary by GovInfoNow · govinfonow.com/recall/73870-medspira-mcompass-balloon-catheters-recall-balloon-may-separate-in-rectum · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3072-2017
Cite this page
“Medspira mcompass Balloon Catheters Recall: Balloon May Separate in Rectum.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73870-medspira-mcompass-balloon-catheters-recall-balloon-may-separate-in-rectum. Based on FDA recall #Z-3072-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3072-2017%22&limit=1).
Why it’s dangerous
The balloon bond in the inner catheter stem may fail during use, causing the balloon to separate from the stem. This leaves the balloon inside the rectum, which could cause injury or complications during medical procedures.
Who’s affected
Patients using the mcompass Biofeedback Anorectal Manometry System for anorectal pressure studies are affected. Those with the specific part number RMD-002-004 and lots 160627-10 or 160627-11 are most at risk.
How to tell if you have this one
Check for part number RMD-002-004 on the balloon catheter. The affected units were sold with lot numbers 160627-10 or 160627-11.
- Brand
Medspira- Category
Medical device
What to do — step by step
Check Product Details
Look for part number RMD-002-004 and lot numbers 160627-10 or 160627-11 on the balloon catheter.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Idaho, Iowa, Texas.
Recall timeline
FDA terminated this recall 4.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3072-2017 (June 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3072-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.