The Recall Desk

Manufacturer

BIOTRONIK, Inc.

26 recalls in our database name BIOTRONIK, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
26
Critical
0
Severe
5
Most recent
2021-04-28

Of the 26 recalls from BIOTRONIK, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (19%) 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.

26–26 of 26

  • ModerateFDA (Devices)·Z-2376-2015·2015-08-19

    Biotronik Recalls Unapproved Pacemaker Programmer Software Versions

    Biotronik is recalling specific pacemaker programmer software versions because they are not approved for use in the United States.

    Product
    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
    Category
    Medical Device
    Distribution
    Distributed nationwide