No image published for this recall

No image published for this recall

Medtronic Cardiac Rhythm And Heart Failure CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators - safety alert

Official notice

28 Jun 2023

Last checked

28 Jun 2023

Critical riskFDA

An official FDA notice concerns Medtronic Cardiac Rhythm And Heart Failure CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators - safety alert. An official FDA notice concerns CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-06-28. Lots: Serial. Recall numbers: Z-1785-2023. Check the official notice for the complete list. Published 2023-06-28.

What to do now

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

Units affected

462

Recall number

Z-1785-2023

Official notice

2023-06-28

The hazard

An official FDA notice concerns CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-06-28. Lots: Serial. Recall numbers: Z-1785-2023. 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

Serial

Event Ids

92328

Recall Numbers

Z-1785-2023

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Affected products

Product 1

CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators

Units affected

462

Risk / hazard

An official FDA notice concerns CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-06-28. Lots: Serial. Recall numbers: Z-1785-2023. 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-1785-2023

Event id

92328

Units affected

462

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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