Teleflex Arrow FiberOptix and UltraFlex (IAB) Catheter Kits Recall Identified as FDA Class I

The company, along with its subsidiary Arrow International, recalled the devices after finding that a manufacturing error had the potential to cause the catheter’s balloon to become overtwisted.

Katie Hobbins, Managing Editor

June 14, 2024

3 Min Read
FDA recall
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Teleflex and its subsidiary Arrow International recently received FDA Class I designation for its recall of the Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) catheter kits after reporting a manufacturing issue that could prevent full balloon inflation. The catheter kits are used with a balloon pump for patients undergoing cardiac and non-cardiac surgery, as well as an option to treat adult patients with acute coronary syndrome or complications of heart failure.

The company’s recalled the kits through a correction, not a product removal, after finding that a manufacturing error had the potential to cause the catheter’s balloon to become overtwisted. The twisting can at times be identified visually, but not always. If identified in a patient, the issue could prevent the balloon from fully inflating, cause blood to back up in the tubing, allow helium to leak, and lead to catheter damage, or difficulty during use, according to FDA’s notice. Use of the device could cause blood loss, tearing in the artery, unstable blood pressure, prevention of blood flow to the heart, and death. Currently, Teleflex and Arrow have received 322 complaints, including a total of 31 injuries and three potential deaths.

On April 29, Teleflex and Arrow sent out an Urgent Medical Device Notification letter to customers recommending that healthcare professionals ensure that a back-up intra-aortic balloon catheter is available before using the kit in case a replacement is needed, inspect all intra-aortic balloon catheters affected by the correction for signs of an over-twisted balloon wrap or bent balloon shaft before use — as catheters suspected of defects should not be inserted, and use fluoroscopic guidance to insert all intra-aortic balloon catheters identified as being part of the recall.

“Once inserted and connected, fluoroscopy must be used to assess the completeness of balloon inflation. Fluoroscopic assessment must span the full length of the balloon (panning as necessary) and should include several cycles of inflation/deflation,” according to the recall notice. “Intermittent fluoroscopy should remain available for up to 3 minutes after one-to-one cyclic counterpulsation begins, or until full balloon inflation is confirmed.”

Additionally, the company said to be vigilant when responding to pump alarms consistent with the device’s instructions for use and users guide, and to also be vigilant when responding to bedside indicators that the catheter is not working as expected, including blood in the helium pathway and lower than expected diastolic pressure augmentation.

“If an Arrow AC3 or Autocat-2 pump is being used, a high-pressure alarm or high baseline alarm may sound and display on the pump console. These red-condition alarms require immediate attention per the Instructions For Use and Users Guide,” according to the notice. “The alarms provide users with a trouble shooting algorithm that includes incomplete IAB inflation. If a Getinge CardioSave pump is being used, an IAB catheter restriction alarm may sound. Any pump alarm indicating helium leakage (helium loss or gas loss) may signal the IAB catheter is not performing as expected.”

If the issue is identified or suspected, FDA urged providers to immediately remove the catheter and replace it using the steps outlined in the instructions for use.

“A replacement balloon catheter may be inserted contralaterally or ipsilaterally as determined by the responsible physician after considering the patient’s individual femoral access options and relevant clinical features,” the FDA notice wrote.

Teleflex and Arrow said to promptly report every suspected defective device to the company using the contact information provided in the FDA notice.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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