Class II — Sorin Group Italia S.r.l.
| Recalling firm | SORIN GROUP ITALIA S.R.L |
|---|---|
| Registered facility | SORIN GROUP ITALIA S.R.L (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | ORCHESTRA/ORCHESTRA PLUS Programmer |
| Quantity | 1,718 |
| Distribution | Nationwide. |
| Initiated | 2013-11-20 |
| Classified | 2014-01-22 |
| Terminated | 2014-09-08 |
| Recall number | Z-0805-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sorin Group Italia S.r.l. (Z-0805-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67013/
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