VenaSeal Closure System — Class III medical device recall Z-1564-2021
Terminated recall by Medtronic Inc., reported 2021-05-19, distributed nationwide. Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the a
| Recall number | Z-1564-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Plymouth, MN, United States |
| Recall initiated | 2021-03-23 |
| Classified | 2021-05-12 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2026-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 154,152 units |
| UPC / GTIN / UDI-DI | 00613994384089, 00643169437937, 00643169437975, 00643169931459, 00673978070469, 00673978070872, 00763000240776, 00763000279769, 20643169986262, 20643169986279 |
| Serial numbers | 49967, 50226, 50229, 50431, 50547, 50651, 50816, 50832, 50833, 50972, 51017, 51076, 51077, 51178, 51195, 51307, 51310, 51461, 51509, 51590, 51657, 51659, 51660, 51752, 51755 and 475 more |
| Model numbers | SP-101, VS-402, VS-404 |
Product
VenaSeal Closure System
Reason for recall
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1564-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.