FDA MedWatch Safety Alerts

FDA Early Alert: Erbe USA Cryoprobes Rupture Risk

The FDA issued an Early Alert regarding Erbe USA Flexible Cryoprobes due to a risk of rupture during activation, potentially causing injuries and hearing loss. Erbe USA has recalled affected lots and recommended discontinuing use.

Integra LifeSciences Recalls MediHoney and CVS Wound Dressings

The FDA announced a recall initiated by Integra LifeSciences for certain MediHoney and CVS Wound Gel products due to packaging failures that could lead to infection or delayed care. The recall involves removing affected products from service and distribution. Integra LifeSciences has reported 11 serious injuries related to MediHoney and three related to CVS Wound Gel.

Medline Industries Recalls Catheters Due to Particulates and Infection Risk

The FDA has identified a Medline Industries catheter recall as the most serious type due to potential particulates causing infection or embolism. Affected product lots must be destroyed. This is an expansion of a previous recall.

FDA Safety Communication on Choking Rescue Protocols and Devices

The FDA is issuing a safety communication to encourage the public and healthcare providers to follow established choking rescue protocols before using anti-choking devices. The agency highlights that established protocols, such as back blows and abdominal thrusts, are the most effective method and that using devices first could delay life-saving actions.

Trividia Health Corrects True Metrix Blood Glucose Meters Due to Injuries and Death

The FDA issued an Early Alert regarding Trividia Health's correction of TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems due to reports of injuries and death. The correction updates instructions for the E-5 error code, which indicates very high blood glucose results or test strip errors.

Olympus Insufflation Units Recalled by FDA Due to Software Issues

The FDA has classified a recall of Olympus High Flow Insufflation Units (models UHI, UHI-2, UHI-3) as Class I due to a software issue that could lead to overpressure events, potentially causing serious injury or death. Olympus is removing these discontinued devices from the market, and users are instructed to immediately cease usage and quarantine affected units.

FDA Early Alert: Abiomed Heart Pump Purge Cassette Issue

The FDA issued an Early Alert regarding a potentially high-risk issue with Abiomed's Impella Purge Cassettes and Pump Sets. The issue involves an increased risk of purge leaks in Generation 1 Purge Cassettes, which could lead to pump stops and patient death. Abiomed has recalled affected products, and four serious injuries have been reported.

Boston Scientific Recalls AXIOS Stents Due to Deployment Issues

The FDA is alerting the public about a recall of Boston Scientific AXIOS Stents and Electrocautery Enhanced Delivery Systems due to issues with stent deployment. The recall has been identified as the most serious type, with 167 injuries and 3 deaths reported. Healthcare providers are instructed to immediately stop distribution or use of affected devices.