Sorin Defibrillators Recalled for Undetectable Battery Depletion
Sorin is recalling specific defibrillator models because battery depletion may be undetectable. Physicians are being notified to check affected devices.
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 recall is classified as FDA Class II and involves a structural defect (undetectable battery depletion) in a life-sustaining medical device, which meets the criteria for a Severe rating.
Plain-English summary
Sorin Group Italia SRL is recalling specific models of implantable defibrillators, including the OVATIO, PARADYM, and INTENSIA series. The recall involves 3,096 units that were distributed nationwide in the United States.
The recall is being issued because the battery depletion in these specific defibrillators may be undetectable. This issue could prevent the device from functioning as intended for patients at high risk of sudden cardiac death.
Sorin is notifying physicians to identify and address the affected devices. Patients with these specific models should contact their healthcare provider for further instructions.
The recalled product
- Product
- OVATIO Models: VR 6250, DR 6550, CRT 6750. 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 d
- Manufacturer
- Sorin Group Italia SRL - CRF
- Affected units
- 3,096
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 (3)
- Product Code: OH61U
- OH60U
- OH62U
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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