The Recall Desk

Manufacturer

Nucryo Vascular Inc.

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2019-11-27

Of the 1 recalls from Nucryo Vascular 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

  • ModerateFDA (Devices)·Z-0507-2020·2019-11-27

    Nucryo PolarCath Balloon Catheters Recalled for Incorrect Sterilization Labeling

    Nucryo Vascular Inc. is recalling 49 PolarCath Balloon Catheters because they were mislabeled as ethylene oxide sterilized instead of E-beam sterilized.

    Product
    The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths.
    Category
    Medical Device
    Distribution
    6 states