Health product recall

Corvocet Biopsy System

Last updated

Summary

Product
Corvocet Biopsy System
Issue
Medical devices - Performance issue
What to do

Return device(s) to Merit. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Corvocet Biopsy System More than 10 numbers, contact manufacturer. CORA1410 CORA2020 CORCA1825B CORCA2015B CORA1615 CORA1810 CORA1810S CORA1815S CORA1610 CORA1820 CORCA2010B CORA2015 CORCA1615 CORCA1815B CORCA2020B CORA1815 CORA1415 CORA2015S CORCA1810B CORCA1820B CORCA1610 CORA1820S CORA1825 CORA2010 CORCA1815SB

Issue

Merit Medical Systems, Inc. is voluntarily conducting a recall of the Corvocet™ Biopsy System due to a product defect resulting from incorrect assembly. Merit was made aware of the defect as a result of five (5) customer complaints (no adverse/reportable events) received between November 17, 2021, and June 20, 2022, from 4 US accounts and 1 Japanese account. Three (3) complaints were reported in the month of June, 2022.

Recall start date: August 8, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies

Merit Medical Systems Inc.

1600 West Merit Parkway, South Jordan, Utah, United States, 84095

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64490