Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Sorin Group Italia SRL - CRF
Category: Medical Device — Implantable Defibrillator
Hazard: battery-depletion
device-failure
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 →

Same manufacturer · Sorin Group Italia SRL - CRF

See all →

Severe
Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
High
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
High
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
Severe
Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
High
Sorin Platinium CRT-D Recall for Potential Overconsumption After ESD or MRI
FDA (Devices) · 2017-10-04

Same hazard · battery depletion