Medtech Recall Round-Up: June 2024

Getinge’s recall of its Vaporizer Sevoflurane Maquet Filling was identified as FDA class I after the company relayed the potential exposure for patients and healthcare professionals to hydrogen fluoride, a toxic and dangerous chemical.

The company recalled the device after receiving reports of discoloration and corrosion within the vaporizer after it was used with low water content sevoflurane manufactured by Piramal or Baxter. Sevoflurane used in the vaporizer can degrade to hydrogen fluoride, a toxic and hazardous acid.

When inhaled, hydrogen fluoride can cause irritation of the respiratory tract, leading to lung edema, or hypocalcemia. On the skin, the acid may cause blistering, skin wounds, or hypomagnesemia. When an incident like this occurs, Getinge said that use of these device would cause serious injury, health consequences, or death. Currently, the company said they have received two reported incidents and no injuries or deaths related to the issue.

Teleflex and its subsidiary Arrow International received FDA Class I designation for its recall of the Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) catheter kits after reporting a manufacturing issue that could prevent full balloon inflation.

The company’s recalled the kits through a correction, not a product removal, after finding that a manufacturing error had the potential to cause the catheter’s balloon to become overtwisted. The twisting can at times be identified visually, but not always. If identified in a patient, the issue could prevent the balloon from fully inflating, cause blood to back up in the tubing, allow helium to leak, and lead to catheter damage, or difficulty during use, according to FDA’s notice. Use of the device could cause blood loss, tearing in the artery, unstable blood pressure, prevention of blood flow to the heart, and death. Currently, Teleflex and Arrow have received 322 complaints, including a total of 31 injuries and three potential deaths.

Initially recalled in March, and posted to FDA’s database in May, Philips Respironics’ BiPAP V30, BiPAP A30, BiPAP A40 devices have now been linked to 65 deaths and 952 injuries, according to the agency. The recall began after the company was alerted to a false alarm that can cause the devices to shut down.

What FDA called a “failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss,” the device reportedly has the potential to reboot intermittently for 5-10 seconds then restart with the same patient settings, reboot intermittently for 5-10 seconds then restart with factory default settings, or enter a ventilator inoperative state — therapy stopped, audible and visual alarms present — after three reboots within 24 hours and without a preceding reboot.

Affected devices can result in therapy interruption or loss, which could lead to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death.

Baxter has recalled its Life2000 ventilation systems after it was found that the devices carry a risk of failing to charge or intermittently charging. Affecting more than 2,500 units distributed in the US, the FDA has labeled the recall as Class I.

The apparent issue comes from damage to the battery charger dongle, according to the company. The damage to the dongle prevents the ventilators battery from charging correctly. As the recall is considered a correction, not a product removal, patients are permitted to continue using the device if there is no damage to the dongle and the battery is appropriately charging.

Baxter has recalled its Life2000 ventilation systems after it was found that the devices carry a risk of failing to charge or intermittently charging. Affecting more than 2,500 units distributed in the US, the FDA has labeled the recall as Class I.

The apparent issue comes from damage to the battery charger dongle, according to the company. The damage to the dongle prevents the ventilators battery from charging correctly. As the recall is considered a correction, not a product removal, patients are permitted to continue using the device if there is no damage to the dongle and the battery is appropriately charging.