Class II — Sorin Group Italia SRL - CRF
| 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 is notifying physicians that certain defibrillators' battery depletion may be undetectable. |
| Product | PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly toler… |
| Quantity | 4700 |
| Distribution | US Nationwide Distribution |
| Initiated | 2017-04-11 |
| Classified | 2017-05-18 |
| Terminated | 2020-05-22 |
| Recall number | Z-2113-2017 |
| 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 SRL - CRF (Z-2113-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77139/
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