FDAJuly 28, 2017device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
nxthera
UPCs
08855757006010
Recall history
No related federal recalls on record for this brand yet.
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