FDA Class I Recall: Arrow AutoCAT2 and AC3 Optimus IABP series due to possible breakdown of motor connector wires

July 6, 2020

Arrow International is recalling the Arrow AutoCAT2 Intra-Aortic Balloon Pump and AC3 Optimus Intra-Aortic Balloon Pump Series because both devices have a part within called the MForce motor driver that may break, char, and discolor the motor connector wires. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death. 

Arrow International has received 30 complaints in total about these devices. There were no injuries or deaths reported as a result of any of the complaints. 

This may lead to pump alarms for "System Error 3" and "High Baseline" presented on the screen of the IABP. Furthermore, the IABP may suddenly stop, even without an alarm. This may cause serious patient harm including serious organ damage and death. 

Recalled products are: 

Arrow AutoCAT2 and AC3 Optimus Intra-Aortic Balloon Pump Series

Model, Product Names, Product Codes, and Serial Numbers: See List of Affected Devices

Manufacturing Dates: 08/01/2014 to 01/2020

Distribution Dates: March 15, 2018 to May 1, 2020

Devices Recalled in the U.S.: 2123

Date Initiated by Firm: May 20, 2020 

The Arrow AutoCAT2 and AC3 Optimus are Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure. 

On May 20, 2020, Arrow International Inc. sent an Urgent Medical Device Correction letter to all affected customers. The notice instructed customers to: 

·       Immediately check the inventory for Arrow AutoCAT2 and Arrow AC3 Optimus IABPs, whether stored or in use, and determine if there is an IABP with a model number listed below.

·        If the IABP mentioned in the Urgent Medical Device Correction letter displays a "System Error 3" or "High Baseline" alarm, now or at any point in the future until the company’s Long-Term Corrective Actions specified in the letter occur, immediately quarantine the device and contact Teleflex.

·        Ensure that a backup IABP is available as instructed within the Operator Manual.

·        If no such replacement IABP is immediately available, it is recommended that the risks and benefits of using the IABP be assessed by the medical team treating the patient and that alternative circulatory support devices be considered.

·        Use a backup IABP or alternative therapy in the event an IABP displays a “System Error 3” or “High Baseline” alarm, at the discretion of the attending physician.

·        Closely monitor IABP units should be during delivery of IABP therapy.

·        Use of IABP for ground or air transport between medical facilities is not recommended.

·        If pump shutdown is experienced, take note of the time of day and call knowledgeable maintenance personnel as stated in the Arrow AutoCAT2 Intra-Aortic Balloon Pump / Arrow AC3 Optimus Intra-Aortic Balloon Pump Operator Manuals.

·        Pump shutdown requires immediate staff action. If pumping cannot be restored within 15-30 minutes, manually inflate and deflate the IAB several times per hour to reduce the risk of thrombus formation. Consider removing the balloon. Arrow International recommends there be a back-up IABP system available.

·        Keep a copy of the Urgent Medical Device Correction letter from Arrow International with each IABP at all times until the complete implementation of the company’s Long-Term Corrective Actions specified in the letter.

·        Quarantine the device for inspection, if "System Error 3" and "High Baseline" alarms are experienced at a later time, taking into consideration the use of available alternative therapies, and adhering to the instructions specified under the heading “ACTIONS TO BE TAKEN BY FACILITIES” in the Urgent Medical Device Correction letter. 

FDA has the recall

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