Recalls: Page 8

  • A woman's hand holds a Freestyle Libre diabetes reader
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    Retrieved from Abbott on April 06, 2023
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    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, respirator
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    Courtesy of Philips
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    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 • April 4, 2023
  • Front sign of FDA building Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    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
  • Roy Jakobs, Philips' chief business leader for connected care
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    Permission granted by Philips
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    Philips CEO Jakobs expects first settlement on respirators this year, Dutch newspaper says

    Jakobs said he “hopes and expects” to reach a settlement with the Food and Drug Administration this year; settling suits over alleged medical damages may take longer.

    By Peter Green • March 31, 2023
  • image of the joints recalled by Exatech
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    Courtesy of U.S. Food & Drug Administration
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    Exactech implants may oxidize, FDA says, warning surgeons not to use any recalled joints

    Exactech is recalling knee and total ankle replacements that were packaged in defective bags.

    By • March 24, 2023
  • A photograph of the exterior of the Food and Drug Administration headquarters in Maryland.
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    Getty Images
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    FDA Class I recalls hit 15-year high in 2022

    The jump in activity happened in a year in which the number of all recalls rose by around 10%, including actions by Baxter, Medtronic and Philips.

    By • March 3, 2023
  • Image of Medtronic's Harmony TPV
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    Courtesy of U.S. Food and Drug Administration
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    Medtronic relaunches pulmonary valve that was subject of recall

    Designed to treat a congenital heart defect, the device was launched two years ago, but was recalled after a year.

    By • Feb. 23, 2023
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips executives waive bonuses after year of recalls; ex-CEO gets $222,000

    The waived incentives coincide with an FDA notice about the recall of some reworked ventilators that Philips initiated late last year.

    By • Feb. 22, 2023
  • GE's NM/CT 870 CZT nuclear imaging device
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    Courtesy of GE HealthCare
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    GE’s nuclear imaging device can crush patients, FDA says, as Class I recall issued

    GE HealthCare has told customers to stop using the machines until company technicians can inspect them and replace dangerous parts. 

    By • Feb. 17, 2023
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    Courtesy of Philips
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    82 more deaths linked to Philips’ recalled devices reported to FDA, bringing total to 346

    The rate of death reports per month has risen consistently since Philips began the recall in the summer of 2021.

    By • Feb. 10, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    Medtronic recalls 22,000 hemodialysis catheters for potential hub defect

    The FDA reported two injuries tied to the problem, which could cause leaks across the tubes of the implanted catheters and produce blood clots.

    By • Jan. 30, 2023
  • Elements of LivaNova’s LifeSPARC circulatory support system
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    Courtesy of https://www.livanova.com/advanced-circulatory-support/en-us
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    LivaNova recalls circulatory support device for software fix

    The update is intended to fix a malfunction that could cause its LifeSPARC pump to stop working. 

    By • Jan. 30, 2023
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips will cut 6,000 more jobs to reduce costs after company swung to net loss in Q4

    New CEO Roy Jakobs said Philips has been spreading its resources too thinly and “can't and won't be selling everything everywhere anymore.”

    By • Jan. 30, 2023
  • A Medtronic HVAD pump in the palm of a human hand
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    Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
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    Medtronic asks HVAD users to return batteries with welding defects

    The recall is one of several related to battery issues after the heart pump was pulled from the market.

    By • Jan. 23, 2023
  • A physician holding and endoscope
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    Getty Images
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    Olympus gets two FDA warning letters over safety of reprocessed endoscopes

    The regulator said the companies didn’t adequately test the device assembly process and waited too long to report problems from complaints.

    By • Jan. 12, 2023
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    Courtesy of Philips
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    Philips’ studies argue recalled DreamStation CPAP machines unlikely to harm patients’ health

    In a briefing on testing of the machines, Philips said exposure to degraded foam used to soundproof the devices is unlikely to harm patients.

    By • Dec. 21, 2022
  • Team of surgeons operating on patient in hospital - stock photo Four doctors in hospital operating room with patient lying on operating table. Surgical lights shining on medical team performing operat
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    Getty Images
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    The 10 biggest medtech stories of 2022

    MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.

    By MedTech Dive staff • Dec. 3, 2022
  • A Medtronic HVAD pump in the palm of a human hand
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    Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
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    Medtronic’s HVAD system recalled again amid driveline cover problems

    New issues have continued to surface with the problem-plagued device even after Medtronic pulled it from the market last year.

    By • Dec. 1, 2022
  • Philips CPAP machine
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    Getty Images
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    Philips respirator recall reaches 260 reported deaths, FDA says

    The agency has received 90,000 medical device reports related to foam problems with Philips’ recalled sleep apnea devices and ventilators.

    By • Updated Nov. 23, 2022
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips’ ventilator woes grow as FDA issues alert over replacement foam

    Replacement noise reduction material in Trilogy ventilators can block the air inlet and let trace amounts of particulate matter into the air pathway.

    By • Nov. 18, 2022