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Cardioblate™ Gemini™-s
MEDTRONIC, INC. · Model 49351 · UDI-DI 00763000841607
OCL
Prescription
1
510(k) clearances
770
Adverse events (86 deaths)
17
Recalls
29
Facilities
Description
CLAMP 49351 CARDIOBLATE GEMINI-S FT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-20 | Medtronic Perfusion Systems | Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. |
| 2021-09-27 | Medtronic Perfusion Systems | There is potential for intermittent electrical connectivity between the console and probe. |
| 2020-10-12 | MEDTRONIC ATS MEDICAL, INC. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| 2020-10-12 | MEDTRONIC ATS MEDICAL, INC. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| 2020-10-12 | MEDTRONIC ATS MEDICAL, INC. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| 2020-10-12 | MEDTRONIC ATS MEDICAL, INC. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| 2019-05-29 | AtriCure, Inc. | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used. |
| 2019-01-22 | AtriCure, Inc. | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not util |
| 2019-01-22 | AtriCure, Inc. | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not util |
| 2019-01-22 | AtriCure, Inc. | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not util |
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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.