Article Summary: This article compiles medical device recalls reported to the FDA since mid-April, 2021.
By Maia Anderson, Becker’s Hospital Review, Apr 30, 2021.
Medical device recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are six reported to the FDA since mid-April:
Editor’s note: The recalls are listed from most to least recent.
- Pacific Medical Group recalls infusion pump
Pacific Medical Group is recalling the Alaris infusion pump module model 8100, used to deliver fluids such as medications, nutrients and blood into a person’s body in controlled amounts. The recall is because a component of the device may crack or separate, leading to inaccurate delivery of fluids to patients. There have been 62 complaints reported about the issue, and one death may have been related to the recall.
2. Cordis recalls carotid artery device
Cordis has recalled its Precise PRO Rx US Carotid System, a device used to treat patients with narrowed carotid arteries. The recall is due to a risk of separation in the delivery system, which could cause a stroke. There have been seven complaints about this issue, including five reported injuries. No deaths have been reported.
3. BD recalls ChloraPrep applicator
Becton, Dickinson and Co. is recalling its ChloraPrep applicator, found defective. In some lots, the applicator end cap was improperly secured because of a manufacturing error, which can result in broken glass and solution dropping out of the applicator once activated.
4. Medtronic recalls blood-pumping console
Medtronic is recalling a blood-pumping console after reports of electrical failure causing the device to stop. The device is used to pump and return blood to someone during cardiopulmonary bypass, a procedure that temporarily takes over the function of the heart and lungs during surgery. There have been nine complaints about this issue and three injuries. No deaths have been reported.
5. CareFusion recalls Alaris pump module
CareFusion is recalling the Alaris pump module — an infusion pump and vital signs monitor — because of a risk of the keypad lifting up when fluid enters, which could lead to keys becoming unresponsive or stuck. This could lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected devices.
6. Medtronic recalls heart pump
Medtronic has recalled its HeartWare Ventricular Assist Device, used to help the heart continue to pump blood into the rest of the body, because of the risk of wear and tear to the connector plug, which could damage the controller port metal pins. Damaged controller ports may prevent the power and data cables from being connected to the controller and lead to a full or partial stop of the pump. There have been 12 deaths and eight injuries related to the recall.