Sorin Group Italia SRL - CRF: Medical Device Recall in 2017 - (Recall #: Z-2112-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.

Product Classification:

Class II

Date Initiated: April 11, 2017

Date Posted: May 24, 2017

Recall Number: Z-2112-2017

Event ID: 77139

Reason for Recall:

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

Status: Terminated

Product Quantity: 3096

Code Information:

Product Code: OH61U, OH60U, OH62U

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated