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

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

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

Integra recalls all devices made at Boston facility in the past 5 years, pauses production

Integra initiated the recall after an internal investigation found endotoxin testing deviations that can result in postoperative fevers. Analysts at BTIG said the recall raises “bigger questions” about Integra’s management.

By Nick Paul Taylor • May 24, 2023

Philips loses vote as shareholders push back against handling of respirator recall

The vote will allow investors to sue board members over their actions in 2022. Philips blamed the ballot loss on guidance from proxy advisors.

By Nick Paul Taylor • May 10, 2023

Illumina gets cybersecurity warning from FDA over sequencing software

The vulnerability could result in an attacker gaining control of an instrument remotely and altering genomic data results, the agency said.

By Susan Kelly • Updated April 28, 2023

Post-approval modification of high-risk devices linked to 30% jump in recall risk: study

The authors suggest improved post-marketing surveillance systems may be needed to mitigate risks to patient safety.

By Nick Paul Taylor • April 18, 2023

Fewer Philips replacement devices have reached patients than counted, FDA says

The agency raised concerns that the discrepancy could affect the estimated wait times for patients needing a replacement sleep apnea device.

By Elise Reuter • April 14, 2023

Philips recalls 1,200 reworked sleep apnea devices over fault that can cause therapy failure

The problems keep mounting for Philips, as recently repaired respirators now need to be fixed in a recall the FDA has labeled a Class I event.

By Nick Paul Taylor • April 10, 2023

Abbott faces Class I recall of 4.2M glucose readers on battery fire risks

Readers for Abbott’s FreeStyle Libre glucose monitoring systems could catch fire if improperly stored or charged, the FDA says.

By Peter Green • Updated April 7, 2023

Philips Trilogy Evo ventilators face another Class I recall

More trouble for Philips’ Respironics business as the company flags a problem with ventilators that could lead to under-delivery of oxygen due to inaccurate readings.

By Elise Reuter • April 4, 2023