The Recall Desk

FDA (Devices) recall action 80244

St Jude Medical Inc. recalled 2 products on 2018-07-11

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-07-11
Critical
0
Units
986

Why these products were recalled

The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2018-07-11

    St Jude Medical Recalls Merlin PCS Programmer Software for ICM Battery Display Error

    St Jude Medical is recalling Merlin PCS Programmer Software to address an incorrect low battery indicator on Confirm Rx ICM devices caused by supply chain temperature exposure.

    Product
    Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
    Category
    Distribution
    42 states
  • ModerateFDA (Devices)··2018-07-11

    St. Jude Medical Confirm Rx Insertable Cardiac Monitor Recall

    St. Jude Medical is recalling 986 Confirm Rx Insertable Cardiac Monitors because exposure to sub-freezing temperatures caused a transient battery voltage drop, resulting in an incorrect low battery indicator display.

    Product
    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness
    Category
    Distribution
    42 states