The FDA has flagged three Class I medical device recalls and corrections, affecting neurosurgical tools, dialysis equipment and insulin pumps.
Here are three recalls to know:
- Hemodialysis bloodlines (B. Braun Medical): On April 22, B. Braun issued a correction for certain Streamline and B3 bloodline sets after identifying tubing changes that may cause air bubbles to form during treatment. Risks include treatment delays, blood loss and life-threatening events in severe cases. No serious injuries or deaths have been reported.
- Insulin pumps (Tandem Diabetes Care): On April 22, Tandem issued a correction for certain Mobi insulin pumps due to a software issue that may trigger false motor failure alerts and stop insulin delivery. The issue could lead to hyperglycemia and, in severe cases, hospitalization. Four serious injuries have been reported.
- Cranial perforators (Integra LifeSciences): On April 23, Integra recalled certain Codman disposable perforators and craniotomy kits due to a weld defect that may cause the device to disassemble during use. Potential complications include bleeding, brain injury and death. The FDA reported 10 injuries.
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