vitatron — Class I medical device recall Z-0812-2019
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-0812-2019 |
|---|---|
| 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 | 47,086 units |
| UPC / GTIN / UDI-DI | 00643169709126, 00643169709140, 00643169709164, 00643169709188, 00643169709249, 00643169709263, 00643169709294, 00643169709331, 00643169882980, 00643169882997, 00643169883000, 00643169883017 |
| Model numbers | A30A1, A60A1, E50A1, E60A1, G70A1, G70A2, Q50A2, Q70A2, Q80A2 |
Product
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
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-0812-2019. 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.