6 medical device recalls to know

The FDA has flagged 6 medical device recalls, corrections and early alerts affecting pulmonary valve catheters, infusion pumps, insulin pumps, heart pumps, positive pressure breathing devices, breathing circuits and several convenience kits.

Here are the 6 recalls to know:

1. Positive pressure breathing devices (Baxter): On July 14, the FDA confirmed a Class I recall of all Volara System patient circuits. The circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization. Baxter has reported one serious injury and no deaths.
2. Pulmonary valve catheter delivery systems (Medtronic): On July 13, the FDA confirmed a Class I recall of certain lots of the Harmony Delivery Catheter System used to insert the Harmony transcatheter pulmonary valve. The distal tip may detach during implantation, requiring endovascular retrieval or surgical intervention. The FDA reported no serious injuries or deaths.
3. Convenience kits (Medical Action Industries): On July 9, the FDA issued an early alert for Cath Pack kits containing Namic angiographic control syringes whose rotating adaptor may unwind during use, risking a loose or full disconnection between the syringe and manifold. Medline has reported four serious injuries and no deaths tied to the underlying syringe issue.
4. Breathing circuit sets (Hamilton Medical): On July 2, the FDA confirmed a Class I recall correction for coaxial breathing circuit sets used with HAMILTON-C1, T1 and MR1 ventilators after an expiratory valve membrane adhesion issue was found to obstruct expiratory gas flow. Hamilton Medical has reported four serious injuries and no deaths.
5. Insulin pumps (Insulet): On July 2, the FDA confirmed a Class I recall of certain Omnipod 5, DASH and Eros Pods after identifying a small tear in the cannula tubing that can cause insulin to leak outside the pod. Insulet has reported 24 serious injuries and no deaths.
6. Heart pumps (Abiomed): On July 2, the FDA confirmed a Class I recall of certain Impella CP Sets with SmartAssist that fall outside design specifications and may cause low purge pressure events. Abiomed has reported one death and three pump exchanges associated with this issue.

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