Reported Dec 27, 2017 · Terminated
Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove,…
Nxthera
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NXTHERA · 7351 Kirkwood Ln N · Maple Grove, MN · 55369-5201
Is this the product you have?
- 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.
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot Number of Outside Cases (Pack Lot) 2017020920 with 2 Lot Number of Inside Boxes (Product Lot) 2017011612 and Exp Date 2018-01-31 3 Lot Number of Outside Cases (Pack Lot) 2017030286 with 4 Lot Number of Inside Boxees (Product Lot) 2017011187 and Exp Date 2018-01-31. - Amount recalled
- 113 units total
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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