Recalls
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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 Nick Paul Taylor • March 3, 2023 -
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 Susan Kelly • Feb. 23, 2023 -
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 Nick Paul Taylor • Feb. 22, 2023 -
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 Nick Paul Taylor • Feb. 17, 2023 -
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 Nick Paul Taylor • Feb. 10, 2023 -
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 Susan Kelly • Jan. 30, 2023 -
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 Elise Reuter • Jan. 30, 2023 -
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 Nick Paul Taylor • Jan. 30, 2023 -
Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
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 Elise Reuter • Jan. 23, 2023 -
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 Elise Reuter • Jan. 12, 2023 -
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 Elise Reuter • Dec. 21, 2022 -
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 -
Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
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 Elise Reuter • Dec. 1, 2022 -
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 Elise Reuter • Updated Nov. 23, 2022 -
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 Nick Paul Taylor • Nov. 18, 2022