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Formula 418
COOK INCORPORATED · Model G56625 · UDI-DI 10827002566252
NIN
Prescription
0
510(k) clearances
875
Adverse events (32 deaths)
1
Recalls
16
Facilities
Description
Formula 418, Renal Balloon-Expandable Stent
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.