Events

Recall of Device Recall Rezum System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NXTHERA.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77797
  • Event Risk Class
    Class 2
  • Event Number
    Z-0262-2018
  • Event Initiated Date
    2017-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157922
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
  • 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.
  • Action
    Customers were notified initially by sales representatives on or about July 18, 2017. Any affected devices were to be returned to NxThera. Additionally, a formal recall letter was mailed to customers on approximately July 28, 2017. NxThera's telephone contact information and FEDEX number will be provided on the verification form. For further questions, please call (763) 515-2084..

Device

Device Recall Rezum System
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • 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.
  • Manufacturer
    NXTHERA

Manufacturer

NXTHERA
  • Manufacturer Address
    NXTHERA, 7351 Kirkwood Ln N, Maple Grove MN 55369-5201
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA