Boston Scientific — Class II medical device recall Z-0620-2016
Terminated recall by Boston Scientific Corporation, reported 2016-01-20. The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually
| Recall number | Z-0620-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2015-12-10 |
| Classified | 2016-01-08 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-03-08 |
| Countries outside the US | CO, JM, TT |
| Quantity | 5 |
| Serial numbers | 702961, 702963, 705644, 705666, 705947 |
| Model numbers | L210 |
Product
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Reason for recall
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
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-0620-2016. 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.