ARROW INTERNATIONAL Inc.: Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump

Recall number

Z-0446-2023

Recalling firm

ARROW INTERNATIONAL Inc.

Product

Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump

Status

Open, Classified

Initiated

2022-10-17

Posted

2022-12-15

Terminated

not on file

Reason

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

Root cause

Pending

Action

The firm issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 10/17/2022 by FedEx 2-day mail. To reduce the risk of short battery run time: .Plug IABP into an AC outlet during patient use, and when not in use. .Ensure the battery is fully charged prior to transporting patients, and a fully charged backup IABP device is available. .Replace the batteries when Battery Run Time is less than 90 minutes, there is visual damage to the battery, or Battery has been in service for 3 years. . Perform Battery Load Test at least every 12 months by qualified service personnel. If there is an issue with the battery load, immediately quarantine the device and contact Teleflex Customer Service to report the issue and receive service support for the affected IABP device. If a battery load test has not been performed in the past 12 months, perform battery load test prior to transporting patients with affected IABP devices. .If the IABP device battery fails while in use, immediately connect to an AC power source to continue therapy. .If a source of AC power is not available, transfer the patient to a fully charged back-up IABP device. .If pumping cannot be restored within 15 to 30 minutes, manually inflate and deflate the IAB several times per hour to reduce the risk of thrombus formation and consider removing the balloon. Facility Actions: Send a copy of this notification to all relevant personnel in your organization. Place a copy of this Notice with all affected products. Immediately check your inventory of Arrow AutoCAT2 and Arrow AC3 Optimus IABP, whether stored or in use. Return the Acknowledgement Form to Teleflex Customer Service. Hours of operation are 8am-7pm EST. Telephone: 1-866-396-2111, FAX: 1-855-419-8507 Email: Recalls@teleflex.com.

Quantity

4 units

Distribution

Worldwide

Lot, serial or model codes

UDI/DI (01) 0 0801902 04341 2, (01) 3 0801902 04341 3, All Lot/Serial Numbers

510(k) numbers

["K060309"]

PMA numbers

not on file

Product code

DSP

Firm FEI

3013162291

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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