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OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, P...

FDA Device Recall #Z-2112-2017 — Class II — April 11, 2017

Recall Summary

Recall Number Z-2112-2017
Classification Class II — Moderate risk
Date Initiated April 11, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sorin Group Italia SRL - CRF
Location Saluggia, VC
Product Type Devices
Quantity 3096

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.

Reason for Recall

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

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

Product Code: OH61U, OH60U, OH62U

Other Recalls from Sorin Group Italia SRL - CRF

Recall # Classification Product Date
Z-3231-2017 Class II Platinium VR DF4 1240, Model Number TDF035U, UD... Jul 24, 2017
Z-3233-2017 Class II Platinium CRT-D 1741, Model Number TDF037U, UDI... Jul 24, 2017
Z-3232-2017 Class II Platinium DR DF4 1540, Model Number TDF036U, UD... Jul 24, 2017
Z-3228-2017 Class II Platinium VR 1210, Model Number TDF031U, UDI/GT... Jul 24, 2017
Z-3230-2017 Class II Platinium CRT DF1 1711, Model Number TDF033U, U... Jul 24, 2017

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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