Public recall detail

Corvocet Biopsy System

medium
Recall Safety notice
Quick summary

Quick summary: Corvocet Biopsy System.

Recommended action

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Recall details

Quick summary: Corvocet Biopsy System.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMerit Medical Systems Inc.
ProductCorvocet Biopsy System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64490

Affected products

ProductCorvocet Biopsy System
LotMore than 10 numbers, contact manufacturer.
ModelCORA1410 CORA2020 CORCA1825B CORCA2015B CORA1615 CORA1810 CORA1810S CORA1815S CORA1610 CORA1820 CORCA2010B CORA2015 CORCA1615 CORCA1815B CORCA2020B CORA1815 CORA1415 CORA2015S CORCA1810B CORCA1820B CORCA1610 CORA1820S CORA1825 CORA2010 CORCA1815SB
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCorvocet Biopsy System

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

What you should do

  • Return device(s) to Merit.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesMerit Medical Systems Inc. 1600 West Merit Parkway, South Jordan, Utah, United States, 84095
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64490
Background{}
CompaniesMerit Medical Systems Inc. 1600 West Merit Parkway, South Jordan, Utah, United States, 84095
AudiencesHealthcare
Source updated2022-08-22

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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