The Recall Desk

FDA (Devices) recall action 85904

Medtronic Sofamor Danek USA Inc recalled 6 products on 2020-07-29

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2020-07-29
Critical
0
Units
4,056

Why these products were recalled

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

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.

1–6 of 6

  • ModerateFDA (Devices)··2020-07-29

    Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting,
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    0 states
  • ModerateFDA (Devices)··2020-07-29

    Medtronic Recalls Accurian RF Ablation Cannulas Due to Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probes may catch on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting,
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-07-29

    Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, a
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-07-29

    Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probes catch on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting,
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-07-29

    Medtronic Accurian RF Ablation Cannula Recall for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probe may catch on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting,
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-07-29

    Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, a
    Category
    Distribution
    0 states