Class III — Medtronic Inc.
| Recalling firm | Medtronic, Inc. |
|---|---|
| Registered facility | View this company's 53 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter. |
| Product | VenaSeal Closure System |
| Quantity | 154,152 units |
| Distribution | Distributed nationwide to MA, NY, VT, NH, ME |
| Initiated | 2021-03-23 |
| Classified | 2021-05-12 |
| Terminated | 2026-08-04 |
| Recall number | Z-1564-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Medtronic Inc. (Z-1564-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87619/
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