The Recall Desk

Manufacturer

St. Jude Medical, Cardian Rhythm Management Division

2 recalls in our database name St. Jude Medical, Cardian Rhythm Management Division as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-05-19

Of the 2 recalls from St. Jude Medical, Cardian Rhythm Management Division we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1530-2021·2021-05-19

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2021·2021-05-19

    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
    Medical Device
    Distribution
    Distributed nationwide