Z-0178-2020 Class I Terminated
FDA device recall Z-0178-2020 was initiated by Medtronic Inc. on August 7, 2018 and is designated Class I. Reason for recall: There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. The recall status is terminated (terminated March 29, 2024). Affected quantity: 141,519.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- August 7, 2018
- Termination Date
- March 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141,519
Product Description
Reason for Recall
Distribution Pattern
Distribution was nationwide to consumers and distributors. There was no government/military distribution. Foreign distribution was made to Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Martinique, Namibia, Netherlands, New Caledonia, Norway, Oman, Pakistan, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, and United Kingdom.