Sorin Group Italia SRL - CRF: Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

Agency Publication Date: May 18, 2017

Affected Products

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 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 tachyar

Product Code: OH61U, OH60U, OH62U

Lot Numbers:

OH61U

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 (ma

Product Code: ICV1199, ICV1200, ICV1179, TDF011U, TDF010U, TDF012U

Lot Numbers:

ICV1199

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 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 tachyarr

Product Code: TDF022C, TDF021C, TDF020C

Lot Numbers:

TDF022C

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77139

Status: Resolved

Manufacturer: Sorin Group Italia SRL - CRF

Manufactured In: Italy

Units Affected: 3 products (3096; 4700; 37)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product Code: OH61U, OH60U, OH62U

Lot Numbers:

OH61U

Product Code: ICV1199, ICV1200, ICV1179, TDF011U, TDF010U, TDF012U

Lot Numbers:

ICV1199

Product Code: TDF022C, TDF021C, TDF020C

Lot Numbers:

TDF022C