Recalls

Tandem Issues Correction for t:slim X2 Insulin Pumps

A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.

Recalls

FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

Recalls

Medtronic Recalls Certain Newport Ventilators and Related Service Parts

Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.

Recalls

Tandem Issues Correction for t:slim X2 Insulin Pumps

A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.

BD Issues Correction for Infusion Pump Software

Mar 24, 2025

BD is correcting software for its Alaris Systems Manager and CCE Infusion Adapter after identifying a risk that outdated infusion parameters could be uploaded, potentially leading to incorrect dosing.

FDA Issues Early Alert on Baxter Spectrum Infusion Pump Recall

Mar 5, 2025

The FDA has issued an early alert regarding Baxter’s recall of certain Spectrum infusion pumps due to missing motor mounting screws, which may have occurred during servicing.

Medical Device Recalls Reach Highest Level in Four Years

Feb 18, 2025

Sedgwick brand protection releases a year-in-review analysis of 2024 recall data, including the top five failures for medical devices.

Abiomed Updates Use Instructions for Impella RP Pumps Due to Device Interaction Risk

Feb 14, 2025

Abiomed has updated the use instructions for its Impella RP pumps due to a risk of device interaction that could damage the optical sensor or temporarily stop the pump.

Baxter Issues Correction for Life2000 Ventilator Due to Battery Charger Malfunction

Feb 5, 2025

Baxter is replacing faulty battery chargers in the Life2000 Ventilator system after identifying a defect that triggers alarms and renders the device inoperable.