The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names: Arrow AutoCAT 2, AutoCAT 2 Refurbished, AeroautoCAT 2, AutoCAT 2 Wave, AutoCAT 2 Wave refurbished, AeroautoCAT 2 Wave, AeroautoCAT 2 Wave refurbished, AC3 NA/EMEA, AC3 Optimus NA/EMEA, AC3 Optimus NA/ EMEA, AC3 Optimus Refurbished, AC3 Optimus NA/ AJLA
- Product Models and Codes: See Recall Database entries
- Distribution Dates: July 1, 2022 to September 30, 2022
- Devices Recalled in the U.S.: 2,132
- Date Initiated by Firm: October 17, 2022
The Arrow Intra-Aortic Balloon Pumps (IABP) are cardiac (heart) assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.
Reason for Recall
Arrow International, LLC, a subsidiary of Teleflex, Inc, is recalling Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps after receiving complaints that battery power is not lasting as long as expected. A fully charged battery should last 90 minutes, however, multiple users report the devices are experiencing shorter run times. The battery life warnings, designed to sound at 20, 10, and 5 minutes of battery power remaining, are also inaccurate as the battery depletes more rapidly than indicated.
If the pump’s battery depletes, the pump may stop when operated on battery power only. Sudden stopping of the pump’s mechanical support to the patient’s heart can lead to cardiac arrest, stroke, or death.
There have been 241 complaints, with 135 reported pump stops. No deaths have been reported related to this issue.
Who May be Affected
- Health care personnel providing care using the Arrow AutoCAT 2 or AC3 Intra-Aortic Balloon Pumps.
- People who receive care using Arrow AutoCAT 2 or AC3 Intra-Aortic Balloon Pumps, especially those who will use the devices on battery power at some point in their care.
What to Do
On October 17, 2022, Teleflex sent customers an Urgent Medical Device Notification letter. The letter recommended the following actions for users:
Immediate actions if the intra-aortic balloon pump battery fails:
- Immediately connect to an AC power source to continue therapy.
- Transfer the patient to an alternative intra-aortic balloon pump if AC power is not readily available.
- Keep a backup intra-aortic balloon pump fully charged and readily available.
- If pumping cannot be restored within 15 to 30 minutes:
- Manually inflate and deflate the intra-aortic balloon several times per hour to reduce the risk of thrombus formation.
- Consider removing the balloon.
- Review the intra-aortic balloon pump user manual for additional instructions, cautions, and warnings related to proper battery operation and maintenance.
Actions to reduce the risk of short battery run time:
- Keep the pump plugged into an AC outlet whenever possible during patient use to prevent
- the battery from depleting.
- Keep the pump plugged into an AC outlet when the system is not in use to keep the batteries at a full charge.
- Ensure the battery is fully charged before transporting the patient.
- Have a backup intra-aortic balloon pump fully charged and readily available.
- Ensure the batteries are replaced by qualified personnel (per the operator manual) when:
- Battery run time is less than 90 minutes
- There is visual damage to the battery
- The battery has been in service for 3 years.
- Perform a battery load test every 12 months with qualified service personnel.
- Quarantine any product with a battery load issue and contact Teleflex Customer Service to arrange service.
- Do not transport patients with affected intra-aortic balloon pump devices until a battery load test is performed, if one has not been completed in the last 12 months.
The letter also included required actions for facilities.
- Send a copy of this notification to all relevant personnel in the organization, including, at a minimum, personnel in the following departments:
- Coronary Care
- Interventional Cardiology
- Cardiac Catheter Lab
- Intensive Care (Adult, Pediatric, Neonatal)
- Critical Care
- Emergency Department
- Vascular Access Service
- Operating Room/Service
- Resident Training
- Biomedical Engineering
- Immediately check inventory of Arrow AutoCAT 2 and Arrow AC3 Intra-Aortic Balloon Pumps, whether stored or in use.
- Mark the applicable checkbox on the company’s Acknowledgement Form whether you do or do not have affected product, then return the form to Teleflex Customer Service.
- Place a copy of this corrective notice with all affected products.
Customers with questions about this recall should call Teleflex customer service at 866-396-2111 or email email@example.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.