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Fountain®
Merit Medical Systems, Inc. · Model B · UDI-DI 00884450826331
10
510(k) clearances
28
Adverse events (4 deaths)
4
Recalls
23
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-06 | Merit Medical Systems, Inc. | The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| 2022-10-13 | Boston Scientific Corporation | Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. |
| 2022-05-25 | Boston Scientific Corporation | Product may be mislabeled. |
| 2022-05-25 | Boston Scientific Corporation | Product may be mislabeled. |
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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.