Z-0453-2023Class I

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac...

Name: Z-0453-2023 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac...
Creator: ARROW INTERNATIONAL Inc.
Published: 2022-10-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2022-10-17 / Open, Classified

FDA source

ARROW INTERNATIONAL Inc. began a recall of Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump on 2022-10-17. FDA classified it as Class I and gives the reason as "There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0453-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-10-17
Posted: 2022-12-15
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
FDA 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: [email protected].
Quantity in commerce: 4 units
Distribution: Worldwide
Product codes and lots: UDI/DI (01) 0 0801902 09172 7, (01) 3 0801902 09172 8, All Lot/Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0453-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0426-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0427-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0428-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0429-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0430-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0431-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0432-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0433-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0434-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0435-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0436-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0437-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0438-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0439-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0440-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0441-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0442-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0443-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0444-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0445-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0446-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0447-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0448-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0449-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0450-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0451-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0452-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0453-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0454-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0455-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15
Z-0456-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15

Product code DSP

K060309Class IIAutocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. / cleared 2006-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)