Device Recall Paradym DR Model 8550 and Paradym VR Model 8250

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Cardiovascular Devices

3

Yes

Nationwide Distribution including AL, AZ, AR, CA, CO, CT, FL, GA, IA, MA, MI, MO, MS, NJ, NY, NC, OH, OK, PA, SC,A TN,T X, and WA.

Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy || PARADYM DR 8550 and PARADYM VR 8250 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).