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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Recall of Roche partner’s COVID tests labeled as Class I

The at-home COVID tests, made by SD Biosensor and distributed by Roche, were recalled for bacterial contamination.

By Elise Reuter • Updated June 8, 2023