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.
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
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.
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.
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.
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.
Verify your device model and serial number against the list provided in the recall notice to confirm if it is affected.
Yes, if your device has model number SP-101, VS-402, or VS-404 with the specific serial numbers listed in the recall notice.
No action is required if your device is not listed in the recall notice.
No, the recall includes international units as well, as the VS-403 model is being distributed outside the U.S. starting in summer 2021.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1564-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1564-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
