FDA Issues Class I Recall for Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits

The US Food and Drug Administration has issued a Class I recall for the Arrow International intra-aortic balloon catheter and percutaneous insertion kits made by Teleflex Incorporated.

The reason for the recall is that the sheath body used in inserting the intra-aortic balloon via the femoral artery may detach from the sheath hub during the insertion procedure. This can result in significant bleeding for the patient or an interruption or loss of intra-aortic balloon pump treatment.

To date, the agency has received 13 reports of adverse events related to the use the kits, including six serious injuries and one death.

The FDA recall follows the Urgent Medical Device Recall letter sent by Teleflex Incorporated on February 11, 2016, asking physicians to quarantine any unused products from their inventory and to return all affected products. At that time, the company initiated a worldwide recall of more than 47,000 units distributed to hospitals and medical centers and told the FDA of their actions.

The FDA issues a Class I recall in situations where there is a reasonable chance the use of the product can result in serious adverse health consequences or death.

The agency is asking physicians to report adverse events or quality problems related to the use of the device through the MedWatch Safety Information and Adverse Event Reporting Program. 

• Food and Drug Administration. Arrow International Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated: Class 1 Recall. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm490454.htm. Published: March 11, 2016. Accessed: March 18, 2016.

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