The FDA flagged five Class I medical device recalls affecting ventilators, implants, anesthesia systems and dialysis components.
Here are five recalls to know:
1. TMJ implants (Stryker): On April 15, Stryker updated use instructions for certain TMJ unilateral and bilateral implants after a reported case in which a screw penetrated the cranial vault. Potential complications include cerebrospinal fluid leak and meningitis. One serious injury has been reported, with no deaths.
2. Ventilator valve (Percussionaire): On April 15, Percussionaire updated instructions for its Phasitron 5 in-line valve due to a design limitation that can cause leaks and potential hypoventilation, particularly in neonatal patients. Four serious injuries have been reported, with no deaths.
3. Anesthesia workstations (Draeger): On April 14, Draeger issued a correction for Atlan A350 and A350 XL systems due to ventilator failures tied to manufacturing impurities. The issue may require manual ventilation if mechanical ventilation stops. No serious injuries or deaths have been reported.
4. Dialysis catheter component (Merit Medical): On April 14, Merit Medical recalled its 16F dual-valved splittable sheath introducer due to a defect that may prevent the device from splitting properly. Potential risks include hemorrhage, embolization and impaired catheter function. Two serious injuries have been reported, with no deaths.
5. Ventilators (Philips): On April 15, Philips issued a correction for Trilogy Evo platform ventilators tied to issues including inaccurate tidal volume delivery and delayed obstruction alarms. Three serious injuries have been reported, with no deaths.
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