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
Check against the official notice below — it lists the full affected range.
NxThera Inc. is recalling the Rezum System, Vapor BPH Ablation System, Model Number D2201-003, which is intended to relieve symptoms and obstructions related to benign prostatic hyperplasia. The recall affects 113 units distributed across 20 states (Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Utah, and Washington). The devices are identified by UDI 08855757006010 and specific lot numbers with expiration dates of January 31, 2018.
The recall was issued because the needle bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue during treatment delivery. This defect could potentially compromise the device's ability to function properly during the procedure. The recall record does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: USA Distribution to the states of : AL, AZ, CA, CO, FL, GA, IL, MA, MI, MN, MO, NE, NJ, NY, OH, PA, TN, UT, WA. Quantity: 113 units total Lot/code info: UDI 08855757006010. Lot Number of Outside Cases (Pack Lot) 2017020920 with Lot Number of Inside Boxes (Product Lot) 2017011612 and Exp Date 2018-01-31: Lot Number of Outside Cases (Pack Lot) 2017030286 with Lot Number of Inside Boxees (Product Lot) 2017011187 and Exp Date 2018-01-31.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.