Recalls: Page 7
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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 -
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TrendlineMedical 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 -
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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 -
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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 -
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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 -
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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 -
Retrieved from SD Biosensor / FDA on May 30, 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 -
Courtesy of Integra
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 -
Patrik Stollarz / Staff via Getty Images
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 -
Courtesy of Illumina
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 -
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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 -
Courtesy of Philips
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 -
Courtesy of Philips
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
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