Recalls: Page 3
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Exactech recalls shoulder devices after initially declining to act
After the FDA issued a public safety notice and sent Exactech a warning letter, the firm agreed to recall shoulder implants due to packaging issues.
By Nick Paul Taylor • April 22, 2024 -
Courtesy of Boston Scientific
Boston Scientific recalls blood-blocking agent linked to 2 deaths
Seven injuries and 11 incidents were also associated with the safety issue.
By Nick Paul Taylor • April 18, 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 Abbott
Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths
Biological material can build up and obstruct blood flow in heart failure patients supported by the left ventricular assist devices, the FDA said.
By Susan Kelly • April 15, 2024 -
Courtesy of Philips
Philips restricted from selling respiratory machines in DOJ consent decree
The agreement, filed Tuesday, also has export restrictions to ensure U.S. patients receive remediated devices in a timely manner.
By Elise Reuter • April 9, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls thousands of ventilators over fault linked to 8 serious injuries
A problem with the devices can cause patients to receive the wrong amount of ventilation or too little oxygen, the FDA said in a recall notice.
By Nick Paul Taylor • April 5, 2024 -
Courtesy of U.S. Food and Drug Administration
Teleflex catheterization kit recall linked to 10 injuries, 1 death
Nearly 335,000 devices were recalled due to safety issues, which may cause damage to blood vessel walls, artery blockage or death.
By Nick Paul Taylor • April 4, 2024 -
Sarah Silbiger via Getty Images
Infutronix pulls infusion pumps from US after nearly 3,700 complaints
The company listed six issues that can cause the pumps to stop infusions and otherwise malfunction.
By Nick Paul Taylor • April 2, 2024 -
Sarah Silbiger via Getty Images
Vyaire Medical recalls Airlife resuscitators over defect linked to 2 death reports
The recall covers respiratory support devices made in 2017 or earlier that can fail to provide enough ventilation.
By Nick Paul Taylor • March 22, 2024 -
Courtesy of Abiomed/J&J
Abiomed’s latest Impella recall linked to 129 injury, 49 death reports
The J&J subsidiary warned about the risk of the catheter perforating the heart in updated instructions for use. Impella devices were part of four Class I recalls in 2023.
By Elise Reuter • March 21, 2024 -
N/A via Getty Images
Deep Dive6 ways the FDA can improve medical device recalls
Experts said improving how adverse events are tracked and requiring manufacturers to use electronic notifications could make devices safer.
By Elise Reuter • March 18, 2024 -
Retrieved from Exactech on March 14, 2024
Exactech hit with warning letter over implant packaging
The FDA found faults in the orthopedics company’s analysis of complaints demonstrating defective packaging could have accelerated wear to its implants.
By Elise Reuter • March 14, 2024 -
Courtesy of Abbott
Abbott recalls Heartmate LVAD communication system
The FDA said eight reported injuries have been linked to the problem, which can cause the mechanical heart pump to unexpectedly stop or start.
By Susan Kelly • March 12, 2024 -
Courtesy of Medtronic
Medtronic recalls more than 45,000 catheter tubing units after injury reports
The issue, which is linked to 26 injuries, could result in neurological harm or death, FDA said.
By Nick Paul Taylor • March 8, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls nearly 86,000 syringe pumps over software problem
The company fixed the issues, which are linked to one reported injury, by updating its software.
By Nick Paul Taylor • March 6, 2024 -
Courtesy of Integra
Integra Lifesciences to cut about 60 jobs as it closes Indiana site
Manufacturing will be transferred to a plant in Maryland as part of a strategy to bolster operational efficiency, a company spokesperson said.
By Susan Kelly • Feb. 27, 2024 -
Sarah Silbiger via Getty Images
Medical device recall system ‘failing to meet the needs of public health,’ physicians find
Amid a GAO review of recalls, the physicians advised the watchdog to revisit unique device identifiers and clarify the FDA’s enforcement authority.
By Nick Paul Taylor • Feb. 20, 2024 -
Sara Silbiger via Getty Images
Smiths Medical recalls syringe pumps for software malfunction
The FDA categorized the recall as Class I, noting that the software faults may cause pumps to fail, delaying or interrupting therapy.
By Nick Paul Taylor • Feb. 15, 2024 -
Retrieved from Food and Drug Administration.
Cardinal Health expands recall of Monoject syringes amid compatibility problems
The company said there have been no reports of patient deaths, but noted there is a risk of serious injury or death.
By Nick Paul Taylor • Feb. 5, 2024 -
Patrik Stollarz / Staff via Getty Images
FDA receives more reports of deaths linked to Philips’ recalled respiratory devices
From the start of July to the end of September last year, the agency received more than 7,000 reports that contained 111 deaths.
By Nick Paul Taylor • Feb. 1, 2024 -
Alex Wong/Getty Images via Getty Images
GAO to review FDA’s oversight of medical device recalls
The government watchdog has accepted a request made in December by Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn.
By Ricky Zipp • Jan. 18, 2024 -
Courtesy of Resmed
Resmed’s magnetized masks linked to 6 patient injuries, FDA says
The company contacted customers in November after determining magnets should be kept away from active implants and metallic medical devices.
By Nick Paul Taylor • Jan. 12, 2024 -
Sara Silbiger via Getty Images
J&J’s Megadyne restricts use of electrodes over burn risk, triggering Class I FDA notice
The J&J unit limited the use of the product in children after receiving reports of burn injuries that could be particularly harmful to them.
By Nick Paul Taylor • Jan. 9, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips recalls MRI machines due to risk of explosion
The Food and Drug Administration labeled the recall as a Class I event. There has been one report of a machine exploding in the 22 years the system has been in use.
By Nick Paul Taylor • Dec. 22, 2023 -
Alex Wong/Getty Images via Getty Images
In wake of Philips recall, senators urge review of FDA medical device oversight
Sens. Richard Durbin and Richard Blumenthal said the sleep apnea device maker “did nothing” while patients suffered.
By Susan Kelly • Dec. 14, 2023 -
Tim Boyle via Getty Images
Baxter sends another safety notice about syringe infusion pump errors
The company shared “reinforced guidance” to mitigate the risk of underdosing and interruptions to treatment.
By Nick Paul Taylor • Updated Dec. 6, 2023
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