CARDIOBLATE® GEMINI® 49260Recalls & reported problems
Medtronic, Inc. · CARDIOBLATE GEMINI-S 49260 EN · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994268051), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Apr 20, 2022Class IIOpen, Classified
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Z-1131-2022 · Root cause: Labeling design · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2024Material Deformation; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CARDIOBLATE GEMINI, IT WAS REPORTED THAT THE TIP ON ONE SIDE OF THE JAWS WAS BROKEN. THE ISSUE DID NOT RESULT IN SHORTENED ABLATION. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19077389 ↗
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- Cardioblate® CryoFlex® 65CS1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 death11 reports
- Cardioblate® CryoFlex® 65CS1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 death6 reports
- Cardioblate® CryoFlex® 60SF7Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 report
- Cardioblate® CryoFlex® 60CM1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall0 reports
- Fusion Ablation System 001-700-002Atricure, Inc. · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue1 recall0 reports
- Fusion Ablation System 001-700-001SAtricure, Inc. · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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