The Recall Desk

FDA (Devices) recall action 86666

MEDTRONIC ATS MEDICAL, INC. recalled 4 products on 2020-12-02

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2020-12-02
Critical
0
Units
112

Why these products were recalled

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Devices)··2020-12-02

    Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recalled for Seal Defects

    Medtronic is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe due to potential defects in the sterile barrier pouch seals.

    Product
    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring tem
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    0 states
  • ModerateFDA (Devices)··2020-12-02

    Medtronic Recalls CryoFlex Surgical Ablation Probes Due to Seal Defects

    Medtronic is recalling 3 units of Cardioblate CryoFlex Surgical Ablation Probes because of a potential defect in the sterile barrier pouch seals.

    Product
    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at it
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    Distribution
    0 states
  • ModerateFDA (Devices)··2020-12-02

    Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects

    Medtronic is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.

    Product
    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-12-02

    Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects

    Medtronic is recalling 15 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.

    Product
    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its
    Category
    Distribution
    0 states