The Recall Desk

FDA (Devices) recall action 77509

St. Jude Medical, Inc. recalled 6 products on 2017-07-19

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
2017-07-19
Critical
0
Units
19,219

Why these products were recalled

The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

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

  • HighFDA (Devices)··2017-07-19

    St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators

    St. Jude Medical is recalling 373 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices may cause a loss of neuromodulation therapy.

    Product
    Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
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  • HighFDA (Devices)··2017-07-19

    St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators

    St. Jude Medical is recalling 54 Infinity 5 Implantable Pulse Generators due to a risk of therapy loss if exposed to monopolar electrosurgical devices.

    Product
    Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
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  • HighFDA (Devices)··2017-07-19

    St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators

    St. Jude Medical is recalling 40 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices during medical procedures may cause a loss of neuromodulation therapy.

    Product
    Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
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    0 states
  • HighFDA (Devices)··2017-07-19

    St. Jude Medical Recalls Proclaim 5 Elite Implantable Pulse Generators

    St. Jude Medical is recalling 8,780 Proclaim 5 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a…
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  • HighFDA (Devices)··2017-07-19

    St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators

    St. Jude Medical is recalling 443 Infinity 5 Implantable Pulse Generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
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    0 states
  • HighFDA (Devices)··2017-07-19

    St. Jude Medical Recalls Proclaim 7 Elite Implantable Pulse Generators

    St. Jude Medical is recalling 9,529 Proclaim 7 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a…
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    0 states