FDA Issues Class I Recalls for Medtronic, Philips, and Abbott Medical Devices

Medicine Net, November 7 — Recently, the U.S. FDA issued three consecutive recall notices, with Medtronic, Philips, and Abbott each recalling their respective medical devices.

 

November 4: Abbott and Philips Recall Information Released

 

Medtronic Recall Information Released on November 5

 

 

FDA information indicates that Medtronic will recall 1,117 MiniMed insulin pumps with potential cybersecurity risks in the United States, classified as a Class I recall.

 

It is understood that Class I recalls are the most serious type of recall in both the United States and China, as the use of these devices may result in serious personal injury or even death.

 

It is understood that patients with diabetes can use the MiniMed insulin pump to deliver insulin for diabetes management.

 

The pump includes a remote control designed to communicate wirelessly with the pump to deliver a specific amount of insulin to patients with diabetes.

 

Due to potential cybersecurity risks, unauthorized individuals (patients, patient caregivers, or medicalHealthcareindividuals other than the provider) may record and replay the wireless communication between the remote controller and the MiniMed insulin pump.

 

Therefore, the pump may be instructed to deliver excessive insulin to the patient, resulting in hypoglycemia (low blood sugar), or to stop insulin delivery, resulting in hyperglycemia and diabetic ketoacidosis, or even death.

 

To date, the FDA has not identified any reports of patient harm associated with these potential cybersecurity risks.

 

 

According to FDA information, Philips will recall 852 Philips Medical Systems (Cleveland) Forte Gamma Camera Systems in the United States, with a Class I recall level.

 

It is understood that healthcare providers use the Philips Medical Systems ForteGamma camera system to view images of structures or functions within patients’ bodies for diagnosis, treatment planning, and evaluation of variousDisease。

 

Prior to the test, the patient will receive a contrast agent, which will be used as part of the imaging examination.

 

Philips is recalling the Forte Gamma camera system because the detector (660 lbs) may detach from the device without warning, potentially causing serious injuries such as crushing or trapping patients, or even death.

 

Philips Healthcare has received a customer complaint; there are no reports of serious injury or death.

 

 

FDA information indicates that Abbott will recall 381 CentriMag acute circulatory support system motors in the United States, with a Class I recall classification.

 

It is understood that the CentriMag system inHeartThe blood pump can deliver blood to the patient for up to 6 hours during open-heart surgery.

 

The system also provides up to 30 days of temporary circulatory support for patients with cardiogenic shock, offering such support for up to 30 days when the right side of the heart loses its pumping function and blood backs up into the body’s veins (acute right heart failure).

 

Abbott is recalling its CentriMag system due to electromagnetic interference causing calibration system errors, which may lead to pump deceleration or stoppage, a blank console screen, and various inaccurate alarms.

 

If the pump speed slows down or stops, it may cause adverse effects to the patient.HealthConsequences, such as stroke, severe organ damage, or death.

 

When Abbott initiated the recall in August 2019, there were reports of 44 injuries and one death.