Medtronic, Simplera Sensor, REF: MMT-5100JD1
- Company
- Medtronic Minimed Inc.
- Recall Initiated
- May 7, 2025
- Posted
- October 2, 2025
- Recall Number
- Z-0033-2026
- Quantity
- 1,440 units
- Firm Location
- Northridge, CA
Reason for Recall
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Distribution
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Lot / Code Info
Lot # HG81GLZ/ GTIN: 20763000649580
Root Cause
Process design
Action Taken
On May 7, 2025, Medtronic issued a "Urgent Field Safety Notice" to affected consignees. Medtronic asked consignees to take the following actions: 1. Verify if the sensors you currently have are from the impacted lot. 2. If you have a Simplera" sensor from the impacted lot, do not use this Simplera" sensor and dispose of it according to local regulations. 3. Please contact our helpline/your Medtronic contact at 01923 205167 to request a replacement. 4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter, even if your sensor is unaffected, or if you do not have any sensors from the affected lot.