The FDA has flagged six medical device recalls, corrections and early alerts affecting convenience kits, ventilators, catheter introducer kits and percutaneous catheters.
Here are the six recalls to know:
- Convenience kits (Medline): On Aug. 3, the FDA confirmed a correction for kits containing Huons lidocaine hydrochloride and bupivacaine hydrochloride in dextrose injection, after Huons recalled the injectables following an FDA inspection that identified quality issues. As of May 20, Medline had reported no serious injuries or deaths.
- Convenience kits (Medical Action Industries): On Aug. 3, the FDA confirmed a correction for kits containing Namic manifolds recalled by Medline, after particulate was found in the manifolds’ fluid path, which carries a risk of tissue or organ ischemia or death if introduced into blood circulation. As of May 13, Medical Action Industries had reported no serious injuries or deaths.
- Ventilators (ResMed): On July 31, the FDA confirmed a correction for Astral 100 and Astral 150 ventilators built before October 2024, after ResMed found a leaking supercapacitor can damage circuitry and send the device into a fail-safe state that halts therapy. As of June 23, ResMed had reported five serious injuries and no deaths.
- Catheter introducer kits (Abiomed): On July 31, the FDA confirmed the removal of 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. As of May 15, Abiomed had reported three serious injuries and no deaths.
- Convenience kits (Argon Medical): On July 30, the FDA confirmed a correction for kits containing Spectra Medical Devices lidocaine ampules affected by the same Huons recall, warning that compromised injectables carry risks including infection and, when used in the neuraxial space, cerebral fluid contamination that could progress to meningitis or encephalitis. As of June 1, Argon Medical had reported two serious injuries and no deaths.
- Percutaneous catheters (Boston Scientific): On July 24, the FDA issued an early alert for certain lots of ENROUTE Transcarotid Neuroprotection System and NPS Plus devices tied to reports of arterial sheath tip separation, which can require surgical retrieval and carries a risk of embolism, stroke or thrombosis. As of July 9, Boston Scientific had reported one serious injury and no deaths.
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