5 medical device recalls to know

The FDA has flagged five medical device recalls, corrections and early alerts affecting infant resuscitation systems, catheter introducers, reprocessed electrophysiology and ultrasound catheters, positive pressure breathing devices and insulin pumps.

Here are the five recalls to know:

1. Infant resuscitation systems (GE HealthCare): On June 22, the FDA confirmed a Class I recall of certain Giraffe and Panda infant resuscitation systems and warmers containing an affected M1091607-R blender. The air-oxygen blender knob shaft can loosen, which can affect the delivered oxygen concentration — potentially resulting in hypoxia or hyperoxia in the patient. Facilities are instructed to identify and remove affected devices from use until corrected. The FDA reported no serious injuries or deaths.
2. Catheter introducers (Abiomed/Oscor): On June 18, the FDA issued an early alert after Abiomed and its manufacturing partner Oscor recommended correction of all introducer kits used with Impella heart pumps. Abiomed and Oscor identified a potential for introducer sheath leakage in 14Fr and 23Fr introducers that may increase the risk of access-site bleeding. 
3. Reprocessed electrophysiology and ultrasound catheters (Medline): On June 18, the FDA confirmed a Class I recall expansion covering additional lots of reprocessed electrophysiology and ultrasound catheters. Specific lots may contain small residual particulates on patient-contacting surfaces — if particulate were to dislodge during use and contact circulating blood or the heart, it could produce a granulomatous reaction or thrombus formation, potentially leading to cerebral or pulmonary embolism or deep vein thrombosis. The FDA reported no serious injuries or deaths.
4. Positive pressure breathing devices (Baxter): On June 11, the FDA issued an early alert after Baxter recommended correction of all Volara System patient circuits. The patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization. Clinicians are instructed to inspect the nebulizer cup for damage before each use and replace the circuit if leakage is observed. 
5. Insulin pumps (Insulet): On June 4, the FDA issued an early alert after Insulet recommended removal of certain Omnipod 5, Omnipod Dash and Omnipod Eros pods. Some pods from affected lots may have a small tear in the cannula tubing just above the skin, allowing insulin to leak outside the pod rather than being delivered to the body. Patients are instructed not to use pods from affected lots, to immediately change any in-use pod and to contact their healthcare provider for alternative insulin delivery, if supply runs short.

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.