Medtronic under greater scrutiny as more of its products run into problems

Medical device maker Medtronic have been making the headlines for all the wrong reasons lately. Priding itself as the “global leader in medical technology, services, and solutions”, Medtronic have been at the centre of a fair few recalls for defects and risks that have arisen from the use of their products.

In the latest issues, scrutiny has come from issues with their products and an alleged lack of warning for equipment incompatibility.

Non-Medtronic warning issue

Regulators are warning healthcare providers of adverse effects reported after using non-Medtronic surgical stereotaxic navigation instruments with Medtronic’s NavLocker Tracker. Essentially, this appears to be a case of using non-Medtronic equipment with Medtronic equipment which has led to two people reportedly losing their lives.

The Medtronic branded Navlock Tracker is only designed to be used with other Medtronic devices. Unfortunately, an undisclosed number of patients have suffered injuries in relation to using alternative NavLock Trackers.

Medtronic are aware of the adverse effects and risk of death and have informed regulators of their plans to change their product labelling to provide better warnings to users not to mix brands for the trackers.

There is another recall…

To add to the massive medical corporation’s headache, its MiniMed 640G insulin pumps are running into problems that are reportedly putting patients at real risk of injury.

The high tech pocket-sized device allows for the patient to monitor glucose levels digitally, with graphs and charts to provide visual data on blood sugar levels. However, the keypad buttons on the pumps may “temporarily” get stuck when atmospheric pressure is subject to certain changes; the most example being during air travel.

If the user is unable to use the buttons on the device, patients may not be able to program a bolus or control insulin delivery. For patients with severe diabetes, this inconveniencing defect could be extremely worrisome.

Urgent medical device recall

The giant medical company has issued an “Urgent Medical Device Recall” for “product correction” to inform users and health physicians of the problem they may run into when using the MiniMed 640G insulin pump. Users are advised to be vigilant of any warning messages that come up on screen and to calibrate the device to ensure the right amount of insulin is being delivered.

The notice warns against calibrating after 12 minutes have gone by since a warning comes up as the values provided may no longer be valid. The advice is likely to cause confusion for users and there are concerns that these instructions are not sufficient.

Medtronic recalls

When searching for “Medtronic” alongside keywords like “defect”, “recall” or “problem”, the list seems big. Medtronic’s legal team must be extremely busy with the amount of lawsuits filed for the range of defective products that are reportedly causing problems.

Problematic products include pacemakers, defibrillators, catheters and more. As one of the largest manufacturers of medical devices, there is a question over whether Medtronic are falling short on their responsibilities because of the volume of recalls for their products. They owe a duty of care to healthcare institutions they provide their products to, and of course for the patients who rely on their products as well. In the past few years, Medtronic have been under a lot of scrutiny for a range of problems and issues.

Medical device manufactures need to ensure that all of their products undergo extensive testing to uncover any flaws and vulnerabilities in any number of circumstances.