Recall Z-2609-2011 ยท MRM Defibrillator, Implantable, Dual-Chamber
ela Medical Llc
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 ca
| Date | Jun 22, 2011 (initiated May 2, 2011) |
| Status | Terminated |
| Reason | On February 28, 2011, the company discovered that since the beginning of the US commercial distribution of Paradym DR 8550 and Paradym VR 8250 ICDs in October 2010, the devices included an incorrect version of the Patient Booklet. The company determined that there is no risk of adverse event associated with this labeling error. |
| Root cause | Error in labeling |
| Action | Sorin CRM USA instructed its field representatives on April 27, 2011 via a conference call to attach the correct Patient Booklet (ref. N582,) as an addendum to the device's external packaging, along with a cover letter "Quality Note" dated May 2, 2011 explaining the discrepancy. The field representatives were fedexed the information on May 2, 2011. The letter instructed the Field Representative to attach the correct patient booklet and an addendum, to the outside of the device box. Field Representatives were asked to complete the acknowledgement form by identifying S/N's in which they attached |
| Quantity | 275 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.