Recalls
Johnson & Johnson recalls Impella heart pumps: one patient death reported
The U.S. FDA issued an early alert on Wednesday, Johnson & Johnson's Abiomed recalled some Impella CP heart pumps, involving 7 devices, due to low perfusion pressure issues, which have resulted in one patient death.
Insulet Voluntarily Recalls Approximately 7 Million Patch Insulin Pumps Due to Tubing Leak Risk
Insulet announced a voluntary recall of approximately 7 million patch insulin pumps, affecting certain batches of Omnipod 5, Omnipod DASH, and earlier Omnipod Insulin Management System models. The issue stems from micro-tears in the tubing above the skin, which may cause insulin leakage and lead to severe complications related to high blood sugar. The company has received reports of 24 serious adverse events and expects related costs of up to $50 million this year.
Dexcom Warning: Discarded Glucose Sensors Stolen and Resold on the Market
Dexcom reported on Tuesday that two batches of G7 continuous glucose monitors, which were scheduled for destruction, were stolen during the disposal process and resold by third parties. Some products carry an infection risk due to sterilization failure, while another batch has a high rate of internal test failures, potentially resulting in no readings. The company has not received reports of serious adverse events and has provided channels for inquiries and replacements.