Recall Z-0262-2018— NXTHERA

Name: FDA recall Z-0262-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-28

Class II · Terminated

Class II FDA medical device recall by NXTHERA, initiated 2017-07-28, terminated 2018-08-01. It names one FDA 510(k) clearance: K160417. Product: 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.. Reason: 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..

Recalling firm: NXTHERA
Classification: Class II
Status: Terminated
Initiated: 2017-07-28
Terminated: 2018-08-01
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K160417 — Rezum SystemNxthera, Inc.·cleared 2016-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.