FDA announces Class 1 endovascular system, anesthesia system recalls

Editor's Note

The US Food and Drug Administration (FDA) designated Getinge’s recall of Vaporizer Sevoflurane Maquet Filling and Sevoflurane Quick-Fil and Philips’ recall of Tack Endovascular Systems as Class 1s, the most severe category indicating serious risk of injury or death.

The Getinge recall is an expansion of a 2024 Class 1 Recall, FDA reports. The recall was motivated by reports of discoloration and/or corrosion within the vaporizer after use with low-water-content sevoflurane manufactured by Piramal or Baxter, which can degrade to dangerous hydrogen fluoride. Risks include irritation of respiratory tract, lung edema and/or hypocalcemia, blistering, superficial ulceration, hypomagnesemia, and death. No injuries or deaths have been reported. The full report offers more details and instructions for users.

The Philips Tack Endovascular System recall is reportedly due to usage challenges, including events in which additional interventions were required to retrieve or remove the Tack implant. Risks to patients include occlusion, artery dissection, artery perforation, and long term risks such as pain, tissue loss, restenosis, the need for bypass surgery, amputation, and death.  There have been 20 reported injuries. There have been no reports of death.

All customers should stop using system, and Philips will no longer distribute it.The recall includes models 4F,1.5-4.5 mm, 150 cm;  6F, 3.5 - 6.0mm, 135c; and F, 4.0 - 8.0 mm, 135cm. The full FDA report offers additional information, as well as UDIs and batch codes for specific devices.