The Recall Desk
SevereFDA (Devices)·Z-2114-2017·Announced 2017-05-24

Sorin Defibrillators Recalled for Undetectable Battery Depletion

Sorin Group is recalling 37 implanted defibrillators because battery depletion may be undetectable. Physicians are being notified to monitor affected 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 rubric assigns a score of 4 (Severe) to FDA Class II recalls, particularly those involving significant injury or structural defects in life-sustaining devices.

Plain-English summary

Sorin Group Italia SRL is recalling 37 implanted defibrillators, including INTENSIA, OVATIO, and PARADYM models, due to a potential defect where battery depletion may be undetectable. The affected devices are indicated for use in patients at high risk of sudden cardiac death due to ventricular tachyarrhythmias.

The recall is limited to 37 units distributed nationwide in the United States. The specific product codes associated with this recall are TDF022C, TDF021C, and TDF020C.

Sorin is notifying physicians of this issue. Patients with these specific devices should contact their healthcare provider to discuss the recall and determine if any action is necessary.

The recalled product

Product
INTENSIA Models: VR 124, DR 154, CRT-D 174 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 de
Manufacturer
Sorin Group Italia SRL - CRF
Category
Medical Device — Implantable Defibrillator
Hazard
Affected units
37

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: TDF022C
  • TDF021C
  • TDF020C

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

Same manufacturer · Sorin Group Italia SRL - CRF

See all →

Same hazard · battery depletion

See all →