Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan — Class I medical device recall Z-0807-2019
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2019-02-20. A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 u
| Recall number | Z-0807-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2019-01-17 |
| Classified | 2019-02-14 |
| Reported by FDA | 2019-02-20 |
| Quantity | 9,915 units |
| UPC / GTIN / UDI-DI | 00643169882911, 00643169882928, 00643169882935, 00763000109059, 00763000109066, 00763000109073 |
| Model numbers | ATDR01, ATDRL1, ATDRS1 |
Product
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
Reason for recall
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0807-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.