The Recall Desk

Manufacturer

St. Jude Medical, Inc.

51 recalls in our database name St. Jude Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
51
Critical
1
Severe
8
Most recent
2019-08-14

Of the 51 recalls from St. Jude Medical, Inc. we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (16%) 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.

51–51 of 51

  • LowFDA (Devices)·Z-0617-2013·2013-01-09

    St. Jude Medical Recalls Fast-Cath Transseptal Guiding Introducers Due to Packaging Error

    St. Jude Medical is recalling 26 units of Fast-Cath Transseptal Guiding Introducers because they were packaged with a 180-degree curve instead of the labeled 90-degree curve.

    Product
    Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum
    Category
    Medical Device
    Distribution
    3 states