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.
데이터 추가 비고
Wire, guide, catheter - Product Code DQX
원인
A complaint was received on september 27th, 2016 at a medical center in germany for delamination and flaking of the ptfe lubricious coating on three
findrwirz guidewire system .025 guidewires removed from their packaging hoops.
조치
SentreHeart sent an Urgent Medical Device Voluntary Recall letter dated September 29, 2016, to all affected customers by traceable delivery method. Letters explained the issue and requested that any devices from the two affected lots be returned to SentreHEART immediately. Customers were asked to complete and return the enclosed response form as soon as possible via fax at 650-354-1204 or email to customerservice@sentreheart.com. Customers with questions were instructed to call 1-855-256-7330.
For questions regarding this recall call 650-241-6008.
Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany
제품 설명
FindrWIRZ Guidewire System Catalog# 40-05 || Cardiology: || The system is intended for use in the cardiovascular system for || introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.