The Recall Desk

Manufacturer

SentreHeart Inc

1 recall in our database name SentreHeart Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2016-11-16

Of the 1 recalls from SentreHeart Inc 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.

1–1 of 1

  • LowFDA (Devices)·Z-0328-2017·2016-11-16

    SentreHeart Recalls FindrWIRZ Guidewire Systems Due to Coating Defects

    SentreHeart Inc is recalling FindrWIRZ Guidewire Systems because the lubricious coating delaminated and flaked off three units in Germany.

    Product
    FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
    Category
    Medical Device
    Distribution
    15 states