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NXTHERA: Medical Device Recalls in 2017

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by NXTHERA in 2017. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.
See this for other years:
2017
  • 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 to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.
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