The FDA deemed a recall of the Abbott HeartMate Touch Communication System Class I, the most serious kind of recall. Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero […]
Recalls
Medtronic has a serious catheter tubing recall
The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, […]
Smiths Medical recall affects nearly 86,000 syringe pumps with software issues
Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions. The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump […]
How medtech could be affected by a U.S. government shutdown
Editor’s note: This article originally ran on September 29, 2023. It was updated on February 27, 2024 to reflect new staffing contingency plans and which departments will be affected by the March 1 shutdown. Congressional leaders over the weekend did not come to an agreement on legislation to fund several government agencies, including the FDA. […]
Boston Scientific warns on fragment embolization in some PolarSheath devices
Boston Scientific has issued an urgent field safety notice for some of its PolarSheath steerable sheaths due to the risk of embolization. The company is removing specific batches of PolarSheath steerable sheaths due to a tooling error in manufacturing, which may have caused delimitation of the inner lumen of the sheath shaft in a subset […]
Philips has a serious BrightView recall due to potential falling component
Philips issued a recall notification deemed Class I — the most serious kind — for its BrightView SPECT imaging systems. In December 2023, Philips notified customers about a potential issue with BrightView systems (including BrightView, BrightView X and BrightView XCT). Under specific circumstances, the detector may move downward due to a potential component (lead screw) […]
Philips discontinues certain CPAP product lines after recall saga, stock sinks on Q4 results
Philips has discontinued the U.S. sales of several respiratory device product lines, including one from its much-maligned CPAP portfolio. The company says it agreed with the FDA and the DOJ on the terms of a consent decree focused on the Respironics business. Philips says it provides “clarity and a roadmap” for compliance and the restoration […]
FDA warns on defective packaging with Exactech shoulder system
The FDA issued a warning related to possible health risks associated with the Exactech Equinoxe shoulder system joint replacement devices. Equinoxe devices replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or loss of normal structure and function. The devices also improve previously failed shoulder joint replacement devices with adequate bone and soft tissue […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
ResMed CPAP masks recall is Class I
The FDA announced that ResMed’s voluntary recall of millions of CPAP mask magnets is now Class I, the agency’s most serious level. Last month, ResMed warned CPAP users about potential magnetic interference when magnets go near certain implants and medical devices in the body. People using CPAP masks with magnets only need to return […]
Megadyne Medical recall of patient return electrodes is Class I
The FDA deemed a recall of some Megadyne Medical patient return electrodes, manufactured by J&J’s Ethicon, as Class I, the most serious kind. This action is a correction, not a product removal. Megadyne recalled its Mega Soft Universal, Universal Dual, Universal Plus and Universal Plus Dual patient return electrodes. It initiated the recall on Dec. […]