Here are six warnings the FDA has issued about medical devices since March 1:
1. 135K syringe pumps flagged for delay risk
Smiths Medical has warned customers of more than 135,000 Medfusion syringe pumps about problems associated with earlier software versions.
On March 5, the FDA posted an alert for 85,961 Medfusion Model 3500 Syringe Infusion Pumps, and two weeks earlier, the agency published a warning related to 50,743 Model 4000 syringe pumps. Smiths Medical told its customers to confirm all pumps have the most recent Medfusion software installed. Two injuries have been reported, and no devices have been recalled.
2. 26 injuries reported in Medtronic device recall
Medtronic Neurosurgery is recalling 45,176 Medtronic Duet External Drainage and Monitoring System Catheter Tubing systems because catheters might disconnect from patient line stopcock connectors. There have been 26 reported injuries, the FDA said March 7.
3. Cardinal Health recalls 27M syringes
On March 7, Cardinal Health revised its product correction of more than 27 million syringes to a product removal. The FDA classified it as a Class I recall — the most serious type.
Because of a change in manufacturing and rebranding, the syringes have different dimensions and were made by a new contract manufacturer. The new syringes might be incompatible with syringe pumps and lead "overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding," the FDA said. Zero deaths have been reported.
4. 129 injuries, 49 deaths reported with Abiomed heart pump issue
Abiomed updated warnings on 66,390 Impella Left Sided Heart Pumps because the device might cut the wall of the heart's left ventricle, the FDA said March 21.
After 129 serious injuries, including 49 deaths, have been reported, the device company issued a correction — not a product removal — on the heart pumps.
"With patient safety top of mind, our [instructions document] has been updated with stronger technical guidance around implantation and repositioning," a company spokesperson told Becker's. The new label "emphasizes specific cardiac and peripheral vascular anatomic considerations when implanting Impella."
5. Customers told to destroy 6M resuscitators
Vyaire Medical is pulling 6,633,173 AirLife Adult Manual Resuscitators after reports of patients not receiving enough — or any, in some cases — ventilation. As of March 21, 37 incidents, two injuries and two deaths have been reported in connection to the recall, the FDA said.
Users of the product were advised to discard or destroy the device.
6. After 3.6K complaints, devicemaker recalls infusion pumps
An unspecified number of ambulatory infusion pumps were recalled because of 3,698 complaints related to several product issues, the FDA said March 20.
InfuTronix voluntarily recalled five types of its Nimbus Ambulatory Infusion Pump System after receiving thousands of customer complaints between May 2019 and August 2023. The reports identified problems with battery power, medication infusion, potential leaks and flow rate.