ORCHESTRA/ORCHESTRA PLUS Programmer — Class II medical device recall Z-0805-2014
Terminated recall by Sorin Group Italia S.r.l., reported 2014-01-29, distributed nationwide. Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longev
| Recall number | Z-0805-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group Italia S.r.l., Saluggia, VC, Italy |
| Recall initiated | 2013-11-20 |
| Classified | 2014-01-22 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,718 |
| Model numbers | DR1 |
Product
ORCHESTRA/ORCHESTRA PLUS Programmer
Reason for recall
Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT 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-0805-2014. 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.