Sorin Defibrillators Recalled for Undetectable Battery Depletion
Sorin Group is recalling specific implantable defibrillators because battery depletion may be undetectable, posing a risk to patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. The hazard involves a life-saving medical device (defibrillator) failing to detect battery depletion, which poses a significant risk of harm to patients with life-threatening arrhythmias, meeting the criteria for a Severe rating.
Plain-English summary
Sorin Group Italia SRL is recalling specific models of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected devices include the PARADYM, OVATIO, and INTENSIA series, with a total of 4,700 units distributed nationwide in the United States.
The recall is being issued because the battery depletion in these devices may be undetectable. This defect could prevent the devices from functioning as intended for patients at high risk of sudden cardiac death due to ventricular tachyarrhythmias.
Physicians are being notified of this issue. Patients with these specific devices should contact their healthcare provider to discuss the recall and determine the appropriate course of action.
The recalled product
- 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 indic
- Manufacturer
- Sorin Group Italia SRL - CRF
- Affected units
- 4,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Product Code: ICV1199
- ICV1200
- ICV1179
- TDF011U
- TDF010U
- TDF012U
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Sorin Group Italia SRL - CRF under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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