(CNN) — Medtronic has recalled some of its insulin pumps after injuries and one death were reported due to the device malfunctioning, according to a US Food and Drug Administration announcement on Wednesday.
The FDA identified it as a Class I recall, the most serious type of recall.
Insulin pumps are small devices that can deliver insulin and help diabetes patients reach desired blood glucose levels as part of their management of the disease.
Medtronic has recalled certain MiniMed 600 Series insulin pumps for delivering incorrect insulin dosing due to a missing or broken retainer ring, which helps lock the insulin cartridge in place in the pump’s reservoir compartment, the FDA announcement said. The recall includes about 322,000 devices.
“There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. The retainer ring can be broken, for example, as a result of dropping or bumping your pump on a hard surface,” said a safety notification letter that Medtronic sent to patients in November.
“At Medtronic, patient safety is our top priority, and we are committed to delivering safe and effective therapies of the highest quality and reliability possible. We appreciate your time and attention in reading this important notification,” the letter said.
The FDA announcement said that there have been 26,421 complaints regarding device malfunction, 2,175 injuries and one death.
In these devices, when the insulin cartridge is not properly locked in place that can interrupt how much insulin is delivered, which could lead to hypoglycemia, known as having low blood sugar, or hyperglycemia, known was having high blood sugar. Signs of hypoglycemia include dizziness, confusion and feelings of weakness. Severe cases of hyperglycemia can lead to loss of consciousness, seizure or death.
As listed on the FDA’s website, Medtronic has recalled the following pump models:
- Model 630G distributed in September 2016 to October 2019
- Model 670G distributed in June 2017 to August 2019
The FDA announcement noted that Model 630G may be used by people 16 and older, and Model 670G may be used by people 14 and older. Any users of these devices are encouraged to talk to their doctors.
The letter that Medtronic sent to patients using these pumps encourages them to examine the trainer ring used in their pumps. If the reservoir does not lock into the pump properly or the ring is loose, damaged or missing, the letter says to stop using the insulin pump and instead use manual insulin injections per your doctor’s recommendations.
If your reservoir properly locks in place by the retainer ring, the company said you may continue using your pump, but remember to always follow the device instructions and routinely examine your pump retainer ring, according to the letter. If you happen to drop the pump, check to make sure there is no damage to the device and its retainer ring.
The FDA announcement noted that affected patients can contact Medtronic for a replacement pump if the reservoir does not lock into place properly or if the retainer ring is loose, damaged or missing.
Patients with questions about the recall are encouraged to call the 24-hour Medtronic Technical Support line at 877-585-0166.
This isn’t the first time that there has been a recall of certain MiniMed insulin pumps.
In June, the FDA issued a warning about possible risk of hacking for some of the MiniMed Paradigm models. In its warning at the time, the FDA noted that these devices pose the risk of someone nearby connecting wirelessly and then potentially hacking into the devices.