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: 2022-08-24
Alert / recall type
Health product recall
Category
Health product - Medical device - 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