Recalls
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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 -
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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 Boston Scientific
Boston Scientific recalls Accolade pacemakers tied to 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 • Dec. 17, 2024 -
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 -
Patrik Stollarz / Staff via Getty Images
Philips issues fix for ventilator problems linked to 9 injuries, 1 death
Philips is asking customers to immediately install a software update to address several new and previously reported safety issues, the FDA said.
By Elise Reuter • Oct. 2, 2024 -
magicmine via Getty Images
Recalled heart devices had limited clinical testing, study finds
Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.
By Elise Reuter • Sept. 24, 2024 -
ChooChin via Getty Images
Zimmer pulls hip implant off the market due to fracture risk
The company plans to phase out use of its CPT Hip System by December, but the FDA is still concerned about implants in new patients.
By Elise Reuter • Sept. 18, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls airway tubes over defect linked to more than 10 injuries
Smiths has had seven Class I recalls, the most severe kind, so far in 2024.
By Elise Reuter • Sept. 16, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical links 1 death, 35 injuries to defective airway tubes
Vivek Jain, CEO of parent ICU Medical, recently told investors the company has faced more challenges than expected when it bought the Smiths medical device business in 2022.
By Susan Kelly • Sept. 10, 2024 -
Kahan Shan via Getty Images
Inari updates label of clot removal device linked to 6 deaths
Inari recalled the catheter and revised instructions for use after reports of the device becoming entrapped or blocking patients’ lung arteries.
By Nick Paul Taylor • Aug. 27, 2024 -
Sarah Silbiger via Getty Images
Defibtech recalls chest compression device linked to patient death
Customers are asked to return affected devices due to a problem in the motor that could stop compressions.
By Nick Paul Taylor • Aug. 26, 2024 -
Courtesy of Tandem Diabetes Care
Tandem warns iPhone app still draining insulin pump batteries
Despite a software update in March, users are still reporting that the app is rapidly depleting their insulin pump batteries, causing unexpected shutdowns.
By Elise Reuter • Aug. 15, 2024 -
Retrieved from Breas Medical on August 12, 2024
Breas Medical flags risk of formaldehyde exposure in ventilators
Testing showed the potential for short-term exposure to elevated levels of formaldehyde under specific conditions.
By Nick Paul Taylor • Aug. 12, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls infusion pumps over software issues
The devices may fail to emit alarms, have unresponsive stop and power keys, and reveal passwords.
By Nick Paul Taylor • Aug. 9, 2024 -
Courtesy of Medtronic
Medtronic recalls nerve monitoring system linked to 10 injuries
Medtronic has asked users to be aware the devices may not alert when on a nerve, which could lead to injuries during surgery.
By Nick Paul Taylor • Aug. 7, 2024
