SEVERE WX : Red Flag Warning View Alerts
STREAMING NOW: Watch Now

Medtronic recalls MiniMed insulin pumps as FDA warns about hacking risk

The...

Posted: Jun 28, 2019 3:42 AM
Updated: Jun 28, 2019 3:53 AM

The US Food and Drug Administration issued a warning on Thursday about possible risk of hacking for some diabetes patients' insulin pumps. Certain insulin pumps from Medtronic MiniMed have been recalled due to potential cybersecurity risks and it's recommended for people who use those insulin pumps to switch to different models, according to the FDA.

In its warning, the FDA noted that these devices pose the risk of someone nearby connecting wirelessly and then potentially hacking into the devices.

Insulin pumps are small computerized devices that can deliver insulin therapy to diabetes patients in continuous doses or as a surge around mealtime to help them control blood glucose levels. According to the FDA, the hacker could possibly change the pump's settings to either over-deliver insulin to a patient, which could lead to low blood sugar, or to stop insulin delivery altogether, which could lead to high blood sugar and a life-threatening complication called diabetic ketoacidosis.

In the United States, Medtronic has identified about 4,000 patients who are potentially using insulin pumps that are vulnerable to this issue and the company is working with distributor partners to identify additional patients potentially using these pumps, according to the FDA.

"The FDA urges manufacturers everywhere to remain vigilant about their medical products -- to monitor and assess cybersecurity vulnerability risk, and to be proactive about disclosing vulnerabilities and mitigations to address them," Dr. Suzanne Schwartz, deputy director of the Office of Strategic Partnerships and Technology Innovation and acting division director for All Hazards Response, Science and Strategic Partnerships in the FDA's Center for Devices and Radiological Health, said in a written statement.

"While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm if such a vulnerability were left unaddressed is significant," she said in part. "Any medical device connected to a communications network, like Wi-Fi, or public or home Internet, may have cybersecurity vulnerabilities that could be exploited by unauthorized users. However, at the same time it's important to remember that the increased use of wireless technology and software in medical devices can also offer safer, more convenient, and timely health care delivery."

As listed on the FDA's website, Medtronic is recalling the following insulin pumps:

  • MiniMed 508 (with all software versions)
  • MiniMed Paradigm 511 (with all software versions)
  • MiniMed Paradigm 512/712 (with all software versions)
  • MiniMed Paradigm 515/715 (with all software versions)
  • MiniMed Paradigm 522/722 (with all software versions)
  • MiniMed Paradigm 522K/722K (with all software versions)
  • MiniMed Paradigm 523/723 (with software version 2.4A or lower)
  • MiniMed Paradigm 523K/723K (with software version 2.4A or lower)
  • MiniMed Paradigm 712E (with all software versions)
  • MiniMed Paradigm Veo 554CM/754CM (with software version 2.7A or lower)
  • MiniMed Paradigm Veo 554/754 (with software version 2.6A or lower)

A patient letter on Medtronic's website details how to identify an insulin pump's software.

Medtronic is providing alternative insulin pumps to patients with enhanced built-in cybersecurity capabilities, according to the FDA.

Patients who have questions about replacing their pump can call Medtronic at 1-866-222-2584 or visit Medtronic's website.

The FDA noted that to minimize the potential risk of a cybersecurity attack while waiting on a replacement insulin pump, patients should:

  • Keep their insulin pumps and the devices that are connected to their pumps within their control at all times whenever possible.
  • Not share their pump serial number.
  • Be attentive to pump notifications, alarms and alerts.
  • Monitor their blood glucose levels closely and act appropriately.
  • Immediately cancel any unintended boluses.
  • Connect their Medtronic insulin pump to other Medtronic devices and software only.
  • Disconnect the USB device from their computers when they are not using it to download data from their pump.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 206851

Reported Deaths: 2756
CountyCasesDeaths
Multnomah40371614
Washington26781248
Marion23425323
Clackamas18932235
Lane13908164
Jackson11535146
Deschutes1001882
Umatilla859387
Linn561181
Yamhill478279
Klamath477678
Polk399356
Douglas388483
Malheur361463
Josephine360672
Benton326522
Jefferson237039
Coos216637
Columbia192129
Union149924
Wasco144430
Lincoln143021
Crook129223
Hood River121633
Morrow115416
Clatsop10589
Baker101115
Curry71011
Tillamook6604
Grant5507
Lake4678
Harney4339
Wallowa1945
Gilliam801
Sherman671
Wheeler351
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 3809710

Reported Deaths: 63356
CountyCasesDeaths
Los Angeles124774424456
Riverside3016684627
San Bernardino2992894845
San Diego2818103771
Orange2730575113
Santa Clara1201632188
Kern1107991404
Sacramento1078211736
Fresno1029471724
Alameda896591277
Ventura816611031
San Joaquin747271440
Contra Costa70730813
Stanislaus634971070
Tulare49776849
Monterey43836432
San Mateo42681581
San Francisco37269556
Santa Barbara34613455
Solano33762266
Merced32313478
Sonoma30884317
Imperial28855741
Placer23589299
Kings23195247
San Luis Obispo21421261
Madera16638245
Santa Cruz16246208
Marin14206230
Yolo14160212
Butte12668194
Shasta12630233
El Dorado10396116
Napa1002680
Sutter9663113
Yuba648951
San Benito610963
Lassen578424
Tehama573463
Nevada491975
Humboldt449948
Mendocino434050
Tuolumne421271
Amador374047
Lake356345
Glenn243427
Siskiyou239637
Colusa228418
Calaveras220756
Del Norte14588
Inyo143438
Mono12954
Plumas7366
Modoc5585
Mariposa4657
Trinity4225
Sierra1160
Alpine890
Unassigned280
Medford
Partly Cloudy
96° wxIcon
Hi: 95° Lo: 67°
Feels Like: 93°
Brookings
Partly Cloudy
55° wxIcon
Hi: 71° Lo: 52°
Feels Like: 55°
Crater Lake
Partly Cloudy
96° wxIcon
Hi: 72° Lo: 52°
Feels Like: 93°
Grants Pass
Partly Cloudy
96° wxIcon
Hi: 97° Lo: 65°
Feels Like: 93°
Klamath Falls
Partly Cloudy
72° wxIcon
Hi: 84° Lo: 62°
Feels Like: 72°
Numerous Tuesday Thunderstorms
KDRV Radar
KDRV Fire Danger
KDRV Weather Cam

Community Events