Recalls
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Retrieved from ICU Medical on March 21, 2025
Smiths Medical recalls port implants, warns on endotracheal tubes
The business, acquired by ICU Medical in 2022, has been dealing with a series of recalls and quality issues over the past several years.
By Susan Kelly • March 21, 2025 -
Stock via Getty Images
FDA posts early alert after Calyxo urinary stone device tied to death
The alert describes a problem that can lead to excessive pressure in the kidney during procedures to remove urinary stones.
By Nick Paul Taylor • March 21, 2025 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
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 -
Courtesy of Medtronic
Medtronic recalls embolization devices tied to 17 injuries, 4 deaths
Medtronic will remove one model of Pipeline Vantage devices from where they’re used and sold and will update the instructions for another model.
By Nick Paul Taylor • March 19, 2025 -
Sarah Silbiger via Getty Images
Top device firms report safety data late: BMJ
BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study found.
By Elise Reuter • March 18, 2025 -
Patrik Stollarz / Staff via Getty Images
Philips pulls endovascular implant from market after 20 injuries
Philips stopped selling its Tack endovascular system because of cases where additional interventions were needed to remove the implant.
By Elise Reuter • March 5, 2025 -
Stock via Getty Images
Olympus recalls lung biopsy devices linked to 26 serious injuries
The FDA, which published a Class I recall notice, said the tip of the guide sheath has detached from some devices and fallen off in the patient.
By Nick Paul Taylor • March 4, 2025 -
Courtesy of Medtronic
Medtronic recall of brain fluid drainage systems linked to 15 injuries
The company will keep the systems on the market but is asking providers to check devices for visible cracks and return affected devices.
By Nick Paul Taylor • Feb. 4, 2025 -
Retrieved from Hologic on January 16, 2025
Hologic receives FDA warning letter over Biozorb implantable markers
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
By Elise Reuter • Updated Jan. 16, 2025 -
Patrik Stollarz / Staff via Getty Images
Philips recall of heart monitor software tied to 109 injuries, 2 deaths
Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed by healthcare professionals due to a data routing issue.
By Ricky Zipp • Jan. 14, 2025 -
Sarah Silbiger via Getty Images
FDA posts early alert about safety risk of Medline’s fluid delivery sets
The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are likely to be high-risk recalls.
By Nick Paul Taylor • Jan. 6, 2025 -
Stock via Getty Images
FDA closes 2024 with string of early alerts on device safety risks
Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.
By Susan Kelly • Jan. 3, 2025 -
N/A via Getty Images
Medical device recalls under the spotlight in 2024
Medtech regulators and watchdogs took a closer look at recalls in 2024. Here’s a recap of notable recalls and product safety actions in the past year.
By Elise Reuter • Dec. 19, 2024 -
Courtesy of Boston Scientific
Boston Scientific updates cryoablation catheter instructions after 4 death reports
The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for atrial fibrillation.
By Nick Paul Taylor • Dec. 19, 2024 -
Courtesy of Boston Scientific
Boston Scientific pacemaker recall tied to 832 injuries, 2 deaths
Certain Accolade pacemakers can permanently enter safety mode, which limits the devices’ ability to treat patients properly and requires early replacement.
By Ricky Zipp • Updated Feb. 25, 2025 -
Permission granted by Becton Dickinson
BD to pay $175M to settle charges of misleading investors on Alaris pump
BD will pay a civil penalty to resolve charges it misled investors about risks associated with sales of its Alaris infusion pump, the Securities and Exchange Commission said.
By Elise Reuter • Dec. 17, 2024 -
Sarah Silbiger via Getty Images
FDA plan would alert public sooner on high-risk device recalls
The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of potentially high-risk recalls and when the public is notified.
By Ricky Zipp • Nov. 22, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips revises ventilator directions after airflow issue tied to 4 injuries
Aerosol deposits could accumulate on a sensor and affect oxygen delivery, the FDA said in a recall notice. Several of the ventilator models were previously recalled for separate problems.
By Susan Kelly • Nov. 21, 2024 -
Courtesy of Getinge
FDA warns providers on Getinge devices tied to 17 serious injuries
Getinge recalled endoscopic vessel harvesting devices after receiving 18 complaints in four months. The FDA added the devices to its shortages list following the recall.
By Nick Paul Taylor • Nov. 18, 2024 -
Retrieved from Hologic on May 23, 2024
FDA advises clinicians to stop using Hologic radiographic markers
Hologic has recalled the Biozorb devices after 188 reports of adverse events in patients who received the implants in breast tissue.
By Susan Kelly • Oct. 28, 2024 -
Courtesy of Boston Scientific
Boston Scientific blood-blocking agent tied to additional 2 deaths, 8 injuries
After a February recall, Boston Scientific has warned physicians about new safety risks for Obsidio Embolic, which is now connected to a total of 15 injuries and four deaths.
By Nick Paul Taylor • Oct. 21, 2024 -
Courtesy of Cue Health Press Kit
FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs
Cue Health began the recall of nearly 250,000 COVID-19 test kits in May, shortly after the FDA advised people at home and healthcare professionals not to use the products.
By Nick Paul Taylor • Oct. 17, 2024 -
Sarah Silbiger via Getty Images
Mercury Medical recalls emergency resuscitators
Healthcare professionals use the devices to provide newborns and infants with emergency breathing support.
By Nick Paul Taylor • Oct. 8, 2024 -
Sarah Silbiger via Getty Images
Smiths recalls ventilators over risk of oxygen flow disruption
Smiths has grappled with multiple quality issues and recalls over the past few years. Two recent recalls focus on problems with portable ventilators.
By Elise Reuter • Oct. 7, 2024 -
Courtesy of Medtronic
Medtronic recalls Minimed insulin pumps for reduced battery life
The company said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S. that could be linked to the problem.
By Susan Kelly • Oct. 7, 2024 -
Patrik Stollarz / Staff via Getty Images
Independent lab fires back after Philips sues over testing results
PSN Labs called for a jury trial, claiming Philips is attempting to deflect attention away from its own “failures, negligence, concealment and recklessness.”
By Elise Reuter • Oct. 3, 2024
