Company: Medtronic Inc.
Date of Enforcement Report: 11/13/2019
Class I
PRODUCT
Minimed Model 500 Remote Control for use with the MiniMed 508 Insulin Pump, model number MMT-500RU.
- Recall Number: Z-0177-2020
REASON
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
RECALLING FIRM/MANUFACTURER
Medtronic Inc. on 8/7/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide and International