82 results

• Medical Device Manufacturers Often Fail To Submit Timely Adverse Event Reports to FDA: Study

  March 19, 2025

  Martha Garcia

  The findings of a new study indicate that medical device manufacturers turn in a third of all adverse patient event reports later than legally required.

• FDA Warns About Failure Risks with Fresenius Ivenix Infusion Pumps

  December 12, 2024

  Martha Garcia

  An alert has been issued about problems with Fresenius Ivenix Infusion pumps, due to a risk that the devices may fail to deliver life-saving drugs to patients.

• Zyno Medical Infusion Pump Recall Due to Deadly Risk of Air Embolism

  October 16, 2024

  Irvin Jackson

  Medical providers are being instructed to stop using certain Zyno infusion pumps until a new software update is installed, following reports of air bubbles entering patients’ bloodstreams, which may cause life-threatening injuries.

• Ivenix Infusion Pump Recall Issued Due to Risk of Severe Injury or Death

  October 3, 2024

  Darian Hauf

  Customers are being told to stop using the recalled Ivenix Infusion Pumps until new software is installed, to avoid serious risks that may be caused by the devices delivering reduced doses of medications and fluids.

• lnfusomat Infusion Pump Recall Expanded To Include Additional Devices That May Experience Life-Threatening Malfunction

  September 18, 2024

  Michael Adams

  Braun Medical has expanded an earlier recall of Infusomat infusion pumps due to concerns that life-saving medications may not be properly administered through devices, potentially leading to severe or life-threatening injuries.

• Nimbus Infusion Pump Recall Issued After Thousands of Reports Involving Problems That May Cause Medication Errors

  March 21, 2024

  Hannah Brown

  A Nimbus infusion pump recall has been issued following nearly 4,000 complaints of various device failures.

• Infusomat, Space Infusion Pump Recall Issued After Alarm Failure Linked to Patient Death

  November 20, 2023

  Hannah Brown

  Nearly 11,000 Braun Medical Infusomat and Space infusion pump battery packs due to occlusion sensor failures which could put patients at risk of serious injury or death.

• Sigma Spectrum Infusion Pump Recall Issued After False Alarms Linked to Patient Injuries

  August 1, 2023

  Katherine McDaniel

  Following more than 100 incident reports and three patient injuries, the FDA has announced a Baxter Sigma Spectrum infusion pump recall, warning that false alarms caused by a software upgrade could lead to delays in treatment which endanger patients.

• Ivenix Infusion System Recall Issued Over Risk of Leaks, Serious Injuries and Death

  April 20, 2023

  Irvin Jackson

  The FDA has announced a recall of more than 1,500 Ivenix pediatric infusion pumps due to a risk of leaks which could cause the devices to fail to provide life-saving treatments to children.

• Medfusion Syringe Infusion Pump Recall Issued After Injuries, Patient Death

  July 22, 2022

  Irvin Jackson

  Smiths Medical is recalling more than 118,000 Medfusion infusion pumps which have software problems which could be fatal to patients.