Recall Z-0262-2018 — 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 men greater or equal
U.S. FDA — Device Enforcement · United States · 2017-07-28 · Class II
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Reported risk: Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.
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