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Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2… recallZ-0432-2023 · ARROW INTERNATIONAL Inc. · initiated Oct 17, 2022

Class I Open, Classified All recalls posted in December 2022

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ARROW INTERNATIONAL Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Pending

What the company is doing

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].

Recall details

Recall number
Z-0432-2023
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Oct 17, 2022
Posted by the FDA
Dec 15, 2022
Recalling firm
ARROW INTERNATIONAL Inc.
Quantity
1 unit
Product code
DSP
FDA submissions
K060309
Distribution
Worldwide

Product description

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump

Code information (models, lots, serial numbers)

UDI/DI (01) 0 0801902 05173 8 (11) 170825 (21) 999999W, All Lot/Serial Numbers

Other devices under the same FDA submission

11 devices cleared under K060309 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91021).

Sources and updates

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