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Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump - safety alert

Official notice

21 Dec 2022

Last checked

21 Dec 2022

Critical riskFDA
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An official FDA notice concerns Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump - safety alert. An official FDA notice concerns Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-21. Lots: /Serial. Recall numbers: Z-0427-2023. Check the official notice for the complete list. Published 2022-12-21.

What to do now

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

Units affected

6

Recall number

Z-0427-2023

Official notice

2022-12-21

Watch this recall in the appOpen source hub ↗

The hazard

An official FDA notice concerns Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-21. Lots: /Serial. Recall numbers: Z-0427-2023. 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

91021

Recall Numbers

Z-0427-2023

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Affected products

Product 1

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump

Units affected

6

Risk / hazard

An official FDA notice concerns Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-12-21. Lots: /Serial. Recall numbers: Z-0427-2023. 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 · NC · Morrisville

Affected area 1

US · United States · NC · Morrisville

Affected area 2

US · United States

Company & contacts

Brand

Arrow

Manufacturer

Not provided

Phone

Not provided

Brand: Arrow. Contact: ARROW INTERNATIONAL Inc..

Source & status

Source

FDA

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-0427-2023

Event id

91021

Units affected

6

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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