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Herculink Elite
ABBOTT VASCULAR INC. · Model 1011492-12 · UDI-DI 08717648077975
NIN
Prescription
0
510(k) clearances
874
Adverse events (32 deaths)
1
Recalls
16
Facilities
Description
RX Herculink Elite Renal and Biliary Stent System 5.0 mm x 12 mm x 80 cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-04-15 | Cook Inc. | The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.