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AtriCure cryoICE cryoSPHERE+ Cryoablation System
ATRICURE, INC. · Model CRYOSP · UDI-DI 10840143911729
GXH
Prescription
1
510(k) clearances
53
Adverse events (1 deaths)
2
Recalls
10
Facilities
Description
Cryoablation Probe
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-07-01 | Myoscience Inc | The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels |
| 2013-06-21 | Myoscience Inc | The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caut |
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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.