5 medical device recalls to know 

The FDA has flagged 5 medical device recalls, corrections and early alerts affecting intravascular administration sets, catheter introducer kits, thoracic stent grafts and convenience kits.

Here are the five recalls to know:

1. Intravascular administration sets (Baxter): On July 20, the FDA issued an early alert for certain lots of Duo-Vent solution sets that may develop air bubbles in the drip chamber and tubing during pressure infusions or flushing, risking air entering the IV line. As of July 15, Baxter had reported no serious injuries or deaths.
2. Catheter introducer kits (Abiomed): On July 17, the FDA issued an early alert for 14Fr Low Profile Introducer Kits tied to a higher-than-expected rate of thrombus formation during prolonged use. Because the kits are only compatible with the 10th-generation Impella CP with SmartAssist, that pump set is included in the removal. Abiomed has reported three serious injuries and no deaths.
3. Thoracic stent grafts (Bolton Medical): On July 17, the FDA confirmed a recall of Relay Pro Thoracic Stent Graft System, N4, non-bare stent configurations 32mm and above, after reports the graft can fail to unclasp from its delivery system mid-procedure. Bolton Medical, now part of Terumo Aortic, has linked three deaths to the issue.
4. Convenience kits (Arrow International): On July 16, the FDA confirmed a recall correction for kits containing saline, lidocaine or bupivacaine manufactured by Huons Co. after Huons recalled the injectables over quality issues. Arrow International, a Teleflex subsidiary, has reported no serious injuries or deaths.
5. Convenience kits (B. Braun Medical): On July 16, the FDA confirmed a recall of PENCAN, Spinocan and Spinocan Spinal Tray spinal anesthesia kits containing the same recalled Huons bupivacaine. Because the drug is used in the neuraxial space, risks include cerebral fluid contamination that could progress to meningitis or encephalitis. B. Braun has reported 35 serious injuries and no deaths.

At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.