Arrow Intra-Aortic Balloon Pump Recall Issued Over Battery Failure Risk
Manufacturer warns the aortic balloon pump may fail prematurely due to rapid battery depletion, leading to a disruption in treatment.
More than 2,000 Arrow intra-aortic balloon pumps have been recalled due to battery problems which could cause the heart device to fail, placing patients at high risk of cardiac arrest, stroke and death.
The FDA announced the Arrow intra-aortic balloon pump recall on December 20, designating the action as a Class I medical device recall, suggesting that continued use poses a risk of serious injury or death.
Aortic balloon pumps are cardiac heart assist devices, which are used when a patient is undergoing surgery, both heart surgery and non-cardiac surgery. The devices are typically used for patients who have acute coronary syndrome or complications of heart failure.
The recalled aortic balloon pumps may experience problems where battery power does not last as long as expected. This can lead to disruption of treatment during surgery. To date, the manufacturer is aware of at least 241 complaints of battery issues, including at least 135 incidents where the pump stopped.
A fully charged battery should last 90 minutes, but reports suggest the pumps may last substantially shorter than that. The devices’ battery life warnings are designed to sound at 20, 10, and 5 minutes of power remaining. However, the recall warns these alerts may be inaccurate if the batteries depletes much quicker than indicated.
When the 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.
The recall involves 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, and AC3 Optimus NA/ AJLA.
The devices were distributed from July 1, 2022, to September 30, 2022. So far, more than 2,000 devices have been affected by the Arrow aortic balloon pump recall.
Teleflex first issued an Urgent Medical Device Notification letter on October 17, 2022, warning customers about the problem.
Did You Know?
Change Healthcare Data Breach Impacts Millions of Customers
A massive Change Healthcare data breach exposed the names, social security numbers, medical and personal information of potentially 100 million Americans, which have now been released on the dark web. Lawsuits are being pursued to obtain financial compensation.
Learn MoreThis latest recall came only days after Teleflex announced an Arrow MAC Venous Catheter Kit recall due to a design defect which could cause the catheter connections to leak, which could lead to serious bleeding events or delays in treatment.
Customers with questions about the latest recall can contact Teleflex customer service at 866-396-2111 or email recalls@teleflex.com.
Side effects linked to the device recall should also be reported to the FDA’s MedWatch Adverse Event Reporting Program.
0 Comments