The Recall Desk

FDA (Devices) recall action 87558

St. Jude Medical, Cardian Rhythm Management Division recalled 2 products on 2021-05-19

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
2021-05-19
Critical
0
Units
—

Why these products were recalled

Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-05-19

    St. Jude Medical Recalls Assurity and Endurity Pacemakers Due to Moisture Ingress

    St. Jude Medical is recalling Assurity and Endurity pacemakers because a manufacturing issue with epoxy mixing may allow moisture to enter the device, potentially causing malfunction.

    Product
    ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2021-05-19

    St. Jude Medical Recalls Endurity Pacemakers Due to Epoxy Manufacturing Issue

    St. Jude Medical is recalling 95,042 Endurity pacemakers because a manufacturing issue with epoxy may allow moisture ingress, potentially causing device malfunction.

    Product
    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
    Category
    Distribution
    50 states