Recall Z-0033-2026 ยท MDS Sensor, Glucose, Invasive
Medtronic MiniMed, Inc.
Medtronic, Simplera Sensor, REF: MMT-5100JD1
| Date | Oct 2, 2025 (initiated May 7, 2025) |
| Status | Open, Classified |
| Reason | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection. |
| Root cause | Process design |
| Action | 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 |
| Quantity | 1,440 units |
| Distribution | US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.