No image published for this recall

No image published for this recall

Corvocet biopsy system

Official notice

22 Aug 2022

Last checked

22 Aug 2022

Medium riskHealth Canada

An official Health Canada notice concerns Corvocet biopsy system. 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 Published 2022-08-22.

What to do now

Return device(s) to Merit.

Recall number

64490

Official notice

2022-08-22

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64490

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Affected products

Product 1

Affected products - Corvocet Biopsy System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Merit Medical, Corvocet Biopsy System.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

64490

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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