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

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

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