The Recall Desk

Manufacturer

NXTHERA

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2017-12-27

Of the 1 recalls from NXTHERA 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

  • HighFDA (Devices)·Z-0262-2018·2017-12-27

    Rezum System Recall Due to Potential Needle Bond Failure During Prostate Treatment

    NxThera is recalling 113 Rezum System units because the needle bond may fail during deployment, posing a risk of injury to patients.

    Product
    Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for
    Category
    Medical Device
    Distribution
    19 states