Medtronic MiniMed Paradigm Veo Insulin Pump Recalled for Arabic Translation Error
Medtronic is recalling 239,859 MiniMed Paradigm Veo insulin pumps due to an error in the Arabic language translation of the Predictive Alerts setting screen.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a translation error in a specific language setting, which is a documentation or labeling issue unlikely to cause adverse health consequences, fitting the criteria for a Low severity score.
Plain-English summary
Medtronic Inc. is recalling 239,859 units of the MiniMed Paradigm Veo insulin pump (Product Catalog Numbers MMT-554 and MMT-754). The recall is limited to international distribution, with no U.S. distribution reported.
The recall is due to an error in the Arabic language translation. This error occurs specifically in the Predictive Alerts setting screen, which allows users to program alerts that sound if they are predicted to reach pre-set low or high sensor glucose values.
Consumers with affected units should check their device serial numbers against the list provided in the official recall notice. The source text does not specify a consumer action beyond the recall itself, nor does it report any illnesses or injuries.
The recalled product
- Product
- Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- Affected units
- 239,859
Distribution
Distribution scope not specified by the agency.
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