Medtronic VenaSeal Closure System Recall: Adhesive Not Advancing Properly
Medtronic recalls VenaSeal Closure System models SP-101 and VS-402/404 due to adhesive not advancing through delivery catheter. Affected units have specific serial numbers listed in the recall notice.
Lower-risk recall
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
Contact the company
What happened, in plain English
Medtronic is recalling VenaSeal Closure System devices (models SP-101, VS-402, and VS-404) because the adhesive may not advance properly through the delivery catheter. This could lead to improper closure of blood vessels during procedures. The recall includes specific serial numbers listed in the notice. Read more at govinfonow.com/recall/62995-medtronic-venaseal-closure-system-recall-adhesive-not-advancing-properly.
Source Summary by GovInfoNow · govinfonow.com/recall/62995-medtronic-venaseal-closure-system-recall-adhesive-not-advancing-properly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1564-2021
Cite this page
“Medtronic VenaSeal Closure System Recall: Adhesive Not Advancing Properly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62995-medtronic-venaseal-closure-system-recall-adhesive-not-advancing-properly. Based on FDA recall #Z-1564-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1564-2021%22&limit=1).
Why it’s dangerous
The adhesive in the VenaSeal system may not advance properly through the delivery catheter, which could result in improper closure of blood vessels during procedures. This issue is reported as a problem with the system's performance but does not indicate immediate danger to users.
Who’s affected
Patients who have received VenaSeal Closure System devices with the listed serial numbers are affected. Medical professionals using these devices for procedures are also at risk.
How to tell if you have this one
Check if your VenaSeal Closure System has model number SP-101, VS-402, or VS-404 with the specific serial numbers listed in the recall notice. The recall includes both U.S. and international units.
- Brand
Medtronic- Product
Medtronic Inc. recalls VenaSeal Closure System- Category
Medical device
What to do — step by step
Check Product Details
Verify your device model and serial number against the list provided in the recall notice to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “Distributed nationwide to MA, NY, VT, NH, ME” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maine, Massachusetts, New Hampshire, New York, Vermont.
Recall timeline
FDA published this recall 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall only for U.S. devices?
No, the recall includes international units as well, as the VS-403 model is being distributed outside the U.S. starting in summer 2021.
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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-1564-2021 (March 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1564-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.