Recall Z-0177-2020— Medtronic Inc.

Name: FDA recall Z-0177-2020
Creator: U.S. Food and Drug Administration
Published: 2018-08-07

Class I · Terminated

Class I FDA medical device recall by Medtronic Inc., initiated 2018-08-07, terminated 2024-03-29. It names one FDA 510(k) clearance: K990801. Product: Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).. Reason: There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps..

Recalling firm: Medtronic Inc.
Classification: Class I
Status: Terminated
Initiated: 2018-08-07
Terminated: 2024-03-29
Firm location: Northridge, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K990801 — MINIMED 508 INSULIN PUMPMedtronic Minimed·cleared 1999-06-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).

Reason for recall

There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.

Data sourced from openFDA. This site is unofficial and independent of the FDA.