乌鸦传媒

The FDA announced that Medtronic expanded two recalls relating to the and . Both were designated by the agency as Class I, the most serious type of recall, due to the risk of death or serious injury.

Clear Retainer Ring in 600 Series

For the 600 series, the recall now includes models 630G and 670G, which contain a clear retainer ring that can become damaged and lead to incorrect dosing -- the recall affects 463,464 devices in the U.S.

In an , all MiniMed 600 series insulin pumps featuring a clear retainer ring -- with model numbers 620G, 630G, 640G, and 670G -- are eligible for replacement as part of the recall. Medtronic first warned users about this recall in November 2019, instructing them to evaluate retainer ring damage.

The manufacturer told customers it will replace any pump with a clear retainer ring with one that has the updated black retainer ring at no charge within the "coming months," even if the clear retainer ring is not damaged. This retainer ring works by locking the insulin cartridge into place in the pump's reservoir compartment.

The recall announcement warned patients to immediately stop using the pump, switch to manual injections in the interim, and request a replacement if this clear retainer ring is loose, damaged, or missing, or if the reservoir does not lock into the pump. If the insulin cartridge is not properly locked into place, the pump may deliver more or less insulin than needed, resulting in hyperglycemia or hypoglycemia.

"DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a rapid, and possibly large, insulin bolus," the statement reads in bold text.

If the device has a clear ring, but still properly locks into place, Medtronic advised to continue using the insulin pump until a replacement is issued.

While serious injuries and deaths have occurred with the MiniMed 600 series, none have been directly linked to the clear container rings, FDA noted.

The 630G pump was distributed in the U.S. from September 2016 to February 2020, while the 670G model was distributed from May 2015 to December 2020. The recall does not impact the MiniMed 530G system, 700 series, or Paradigm insulin pumps, which have a different retained ring design.

In an email to 乌鸦传媒, Medtronic noted that since November 2019, the company has replaced nearly half of the clear retainer ring pumps in use in the U.S. -- including fulfilling replacement requests associated with the initial recall for clear retainer rings which were loose, damaged, or missing.

500 Series Remotes

In a separate update, the FDA announced a recall expansion of the MiniMed 508 and Paradigm remote controllers due to cybersecurity risks.

This Class I recall applies to -- including models MMT-500 and MMT-503 -- that are used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of pumps.

Initiated back in August 2018, this recall applies to 31,310 devices in the U.S., which were distributed from August 1999 to July 2018.

These devices, which use older technology, could allow unauthorized persons to hack into the device and instruct the pump to either over-deliver or stop insulin delivery.

"If you have never programmed a remote controller ID into the pump and never programmed the easy bolus option, you are not impacted by this vulnerability," the announcement reads.

Medtronic instructed users to immediately stop using the remote controller, turn off the easy bolus feature, and disconnect the remote controller from the insulin pump.

There have not been any reports of patient harm associated with the cybersecurity risks.

Comment