Recalls
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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 -
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 -
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 -
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 -
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 -
FDA, Health Canada team up to raise awareness of J&J’s Megadyne recall
Agency officials are working together to communicate the risk of burns tied to Megadyne electrode pads.
By Nick Paul Taylor • Aug. 1, 2024 -
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose readings
A spokesperson for Abbott said the recall “may impact less than 1% of Libre 3 users in the U.S.”
By Nick Paul Taylor • July 26, 2024 -
Retrieved from Food and Drug Administration.
J&J limits use of Megadyne electrodes due to burn risk
The FDA said 15 injuries have been tied to the use of three models of Megadyne patient return electrodes.
By Elise Reuter • July 12, 2024 -
Medtronic recalls endotracheal tubes over blockage risk
The Food and Drug Administration has told healthcare providers to stop using the two affected types of endotracheal tubes.
By Nick Paul Taylor • July 11, 2024 -
Philips recall of imaging coils tied to 12 injuries
Several models of coils used in MRI scanners were recalled due to the risk of overheating, which can cause serious burns.
By Ricky Zipp • July 9, 2024 -
Retrieved from Cardinal Health on July 02, 2024
FDA continues crackdown on plastic syringes made in China
The agency has issued import bans for four manufacturers, and multiple companies have recalled affected syringes. Check out MedTech Dive’s roundup of the news.
By Elise Reuter • July 2, 2024 -
FDA walks back injury, death reports on recent Philips BiPAP recall
The agency now says 10 injuries and seven deaths are associated with the problem. The updated numbers match figures shared by Philips and are significantly below the original report.
By Elise Reuter • Updated July 11, 2024 -
Retrieved from Baxter on June 27, 2024
Baxter recalls ventilation systems for charging malfunctions
This comes a year after the healthcare company recalled the Life2000 Ventilation System due to oxygen desaturation risks.
By Ricky Zipp • June 27, 2024 -
Merit Medical recalls plastic syringes made by Jiangsu Shenli
Merit’s recall comes amid broader FDA scrutiny of plastic syringes made in China.
By Nick Paul Taylor • June 17, 2024 -
Teleflex catheter kit recall linked to 31 injuries, 3 deaths
Teleflex reported 322 complaints about a safety problem that can prevent the balloon from fully inflating.
By Nick Paul Taylor • June 14, 2024 -
Masimo embroiled in dual DOJ, SEC probes
Masimo will have to juggle the government inquiries while also dealing with an activist investor-led proxy battle.
By Susan Kelly • June 13, 2024 -
Abbott issues recall for Heartmate system monitor
Abbott’s heart pump system and related products have been part of multiple Class I recalls this year.
By Susan Kelly • June 11, 2024 -
Medtronic recalls neurosurgery navigation system for software error
A problem with the Stealthstation S8 could cause incorrect device placement during surgery. It is the fourth recall of Stealthstation software in the past 12 months.
By Elise Reuter • June 6, 2024 -
Philips reports 7 deaths linked with BiPAP alarm problem
Philips recalled three BiPAP models because an alarm can incorrectly engage and shut down the ventilator under certain circumstances.
By Elise Reuter • May 29, 2024 -
Medline, Chinese manufacturer launch recalls for plastic syringes
Medline and Jiangsu Shenli Medical Production are at the center of the FDA’s probe of plastic syringes made in China.
By Ricky Zipp • May 24, 2024 -
Retrieved from Hologic on May 23, 2024
Hologic recalls more than 53,000 radiographic markers linked to 71 injuries
The Biozorb devices are staying on the market, but Hologic has asked people to report adverse events such as pain.
By Nick Paul Taylor • May 23, 2024 -
Boston Scientific recalls more than 1M angiographic catheters
Hospitals should discontinue use of the devices and return them due to potential safety risks, Boston Scientific wrote in a March letter to customers.
By Susan Kelly • May 15, 2024 -
Abbott recalls Heartmate pump after 70 injuries, 2 deaths reported
In the latest notice, which follows a February recall of the device for a separate issue, Abbott took action due to reports of blood leakage and air entrapment.
By Susan Kelly • Updated May 16, 2024 -
J&J’s Megadyne discontinues pediatric electrode pad after burn reports
Megadyne discontinued the product globally after receiving four reports of patients being burned in procedures when the electrode pads were used.
By Nick Paul Taylor • May 13, 2024