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CardioGenesis
Artivion, Inc. · Model HP-SG3 · UDI-DI 00877234000102
MNO
Prescription
0
510(k) clearances
154
Adverse events (8 deaths)
1
Recalls
1
Facilities
Description
SoloGrip III Handpiece Delivery System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-05-01 | Cardiogenesis Corporation | Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces. |
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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.