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Medtronic Cardiac Rhythm And Heart Failure C315-HIS Delivery Catheter - safety alert

Official notice

3 Nov 2021

Last checked

3 Nov 2021

Critical riskFDA

An official FDA notice concerns Medtronic Cardiac Rhythm And Heart Failure C315-HIS Delivery Catheter - safety alert. An official FDA notice concerns C315-HIS Delivery Catheter. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2021-11-03. Lots: 0010567341, 10568899, 10568900. Recall numbers: Z-0173-2022. Check the official notice for the complete list. Published 2021-11-03.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

591

Recall number

Z-0173-2022

Official notice

2021-11-03

The hazard

An official FDA notice concerns C315-HIS Delivery Catheter. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2021-11-03. Lots: 0010567341, 10568899, 10568900. Recall numbers: Z-0173-2022. Check the official notice for the complete list.

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.

Lots

0010567341, 10568899, 10568900

Event Ids

88688

Recall Numbers

Z-0173-2022

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Affected products

Product 1

C315-HIS Delivery Catheter

Units affected

591

Risk / hazard

An official FDA notice concerns C315-HIS Delivery Catheter. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2021-11-03. Lots: 0010567341, 10568899, 10568900. Recall numbers: Z-0173-2022. Check the official notice for the complete list.

Where it was sold

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

Location 1

US · United States · MN · Mounds View

Affected area 1

US · United States · MN · Mounds View

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic Cardiac Rhythm And Heart Failure. Contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF).

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-0173-2022

Event id

88688

Units affected

591

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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