ARROW INTERNATIONAL Inc. Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Recommended Action

Per FDA guidance

Teleflex/ARROW INTERNATIONAL issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 04/29/2024 via FedEx 2-day mail. 1. Prior to use, ensure that a backup IAB catheter is available. 2. Prior to insertion, inspect all in-scope IAB catheters for signs of an over-twisted balloon wrap or bent balloon shaft. Do not insert catheters suspected of manifesting an over-twisted wrap. 3. Insert all in-scope IAB catheters under fluoroscopic guidance. Use fluoroscopy to assess complete balloon inflation. Span the full length of the balloon, include several cycles of inflation/deflation. Keep fluoroscopy available for up to 3 minutes after one-to-one cyclic counterpulsation begins, or until full balloon inflation is confirmed. 4. Be vigilant in responding to pump alarms consistent with the Instructions For Use and Users Guide (IFU). . when an Arrow AC3 or Autocat-2 pump is used, a high-pressure or high baseline alarm may sound. These red-condition alarms require immediate attention per the IFU. The alarms provide a troubleshooting algorithm that includes incomplete IAB inflation. . when a Getinge CardioSave pump is used, an IAB catheter restriction alarm may sound. . A pump alarm indicating helium leakage (helium loss or gas loss) may signal the IAB catheter is not performing as expected. . Real-time telephone support for Arrow IABPs and IAB catheters is available. 5. Be vigilant in responding to bedside indicators that an IAB catheter is not performing as expected, including Blood in helium pathway and Lower than expected diastolic pressure augmentation. Immediate actions If an IAB catheter is suspected of having this issue: remove and replace the catheter using steps outlined in the IFU. 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.