Recalls
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Courtesy of Hamilton Medical
Hamilton Medical recalls ventilators for control board problem
The issue can cause a short circuit or lead the capacitor to lose function, interrupting ventilation.
By Elise Reuter • Sept. 21, 2023 -
Permission granted by Abbott Laboratories
Abbott’s neurostimulator recall, with 73 injuries reported, deemed Class I by FDA
The company contacted customers in July after receiving complaints from patients who were unable to exit the devices’ MRI mode.
By Nick Paul Taylor • Sept. 14, 2023 -
Courtesy of Hamilton Medical
Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA
The company contacted customers in June after learning that long-term use of the devices could cause them to stop providing active ventilation.
By Nick Paul Taylor • Aug. 31, 2023 -
Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
Medtronic identifies patients at increased risk of heart pump failure
The company has recalled its HeartWare HVAD pump multiple times since it was pulled from the market in 2021.
By Elise Reuter • Aug. 29, 2023 -
Courtesy of Draeger
Draeger’s ventilator sound insulation recall triggers FDA Class I notification
The company found concentrations of a potentially carcinogenic foam component were above acceptable levels for children.
By Nick Paul Taylor • Aug. 24, 2023 -
Courtesy of Integra
Integra receives warning letter related to quality issues at Boston plant
The company recalled all products made at its Boston facility over the last five years, and hopes to restart manufacturing in the fourth quarter.
By Elise Reuter • Updated Aug. 17, 2023 -
Courtesy of Philips
One death, 2 injuries reported in recall of Philips Trilogy ventilators
Philips warned in a previous recall about problems with the devices’ sensors that can lead to under-delivery of oxygen.
By Elise Reuter • Aug. 16, 2023 -
saengsuriya13 via Getty Images
Medtronic’s dialysis device recall assigned to Class I by the FDA
The company contacted customers after routine manufacturing testing identified a blockage that could obstruct the catheter.
By Nick Paul Taylor • Aug. 16, 2023 -
Courtesy of Getinge
Getinge’s heart assist pump shutdown problem given FDA Class I recall tag
The company notified healthcare providers after receiving 26 complaints about Cardiosave devices, used to support severely ill patients, unexpectedly shutting down.
By Nick Paul Taylor • Aug. 11, 2023 -
Boyloso via Getty Images
Baxter recalls infusion pumps over risk of false alarms
Baxter made a software fix last year after it found pumps weren't issuing an occlusion alarm. Now, the devices might issue alarms even when there isn't a blockage.
By Elise Reuter • Aug. 2, 2023 -
Courtesy of Integra
Integra warns impact of plant closure will continue into 2024, with delays possible
Management has built a buffer into the plan but cautioned unforeseen events could cause its timeline to slip.
By Nick Paul Taylor • July 31, 2023 -
Stock via Getty Images
GE HealthCare oxygen sensor recall gets Class I label from FDA
GE warned that the sensors can limit the effectiveness of cardiac defibrillation, expose patients to electrical currents, or give inaccurate blood oxygen readings.
By Nick Paul Taylor • July 31, 2023 -
Courtesy of Abbott Laboratories
Abbott recall of heart catheter categorized as Class I event
Abbott plans to win approval for a modified steerable product and bring it to market as a replacement for the recalled device.
By Nick Paul Taylor • July 27, 2023 -
Courtesy of Philips
Philips reports 9% sales jump, in rebound from sleep device recall
Litigation and a U.S. Justice Department investigation into the recall are ongoing, as are discussions on a proposed consent decree.
By Susan Kelly • July 24, 2023 -
Permission granted by Becton Dickinson
BD gains FDA clearance to relaunch Alaris infusion pump after recalls
The company will fix or replace older devices still in use at hospitals as it ramps up to resume sales in its market-leading infusion business.
By Susan Kelly • July 24, 2023 -
Courtesy of Abiomed/J&J
Four deaths attributed to interference between Abiomed’s heart pump and TAVR stents
There’s a risk that the valve implants can interact with the company’s Impella heart pumps, breaking the motor.
By Elise Reuter • Updated July 28, 2023 -
Courtesy of Medtronic
Medtronic recalls nearly 350,000 defibrillators for risk of reduced shock
The implantable devices may fail to deliver an electric shock to restore normal heart rhythm when needed, which could lead to a serious injury or death, the FDA said.
By Susan Kelly • July 18, 2023 -
magicmine via Getty Images
QuidelOrtho test could miss heart attacks, drawing Class I recall
The company advised clinicians to immediately discontinue using the test and switch to another method if possible.
By Elise Reuter • July 17, 2023 -
Sarah Silbiger/Getty Images via Getty Images
Problem with Draeger transport ventilators categorized as Class I recall by FDA
Draeger contacted customers last month after receiving reports that devices stopped providing ventilation because of depleted batteries.
By Nick Paul Taylor • July 14, 2023 -
Sara Silbiger via Getty Images
J&J Megadyne unit’s electrode pad recall labeled Class I over burn risk
The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths.
By Nick Paul Taylor • July 12, 2023 -
Sarah Silbiger/Getty Images via Getty Images
Teleflex recall of separating vascular catheters labeled Class I event
The company began the recall in May after receiving 83 complaints, including 18 reports of injuries, related to the fault.
By Nick Paul Taylor • June 28, 2023 -
Retrieved from Getinge on June 12, 2023
Getinge’s packaging problems continue with recall of circulatory support devices
The company put a shipping hold on a separate set of life support devices last year due to potential breaches in sterile packaging, which could pose an infection risk.
By Elise Reuter • June 12, 2023 -
Courtesy of Philips
Philips faces new recall of Evo respirators, tagged Class I by FDA
The woes are continuing for Philips and its Respironics unit, whose ventilators and other breathing assist devices have faced a slew of recalls.
By Peter Green • June 6, 2023 -
Courtesy of Abiomed/J&J
Abiomed heart pump recall labeled Class I by FDA, no deaths reported
The recall, tied to specific sets of the Impella 5.5 with SmartAssist, comes just months after Johnson & Johnson paid $16.6 billion for Abiomed.
By Peter Green • Updated June 5, 2023 -
N/A via Getty Images
Deaths reported with Philips ventilators, sleep apnea machines still climbing
The FDA reported 40 additional deaths tied to the recall of Philips’ devices in its latest update.
By Susan Kelly • Updated June 2, 2023
