Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino

FDA device recall Z-2609-2011 · posted 2011-06-22 · Terminated

Recall details

Recalling firm

ela Medical Llc

Reason for recall

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.

Action taken

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 the pouch and their signature of completion and fax the form to 866-500-6096 or e-mail a scanned copy to sorin.ptusa.sorin.com. For questions regarding this recall call 877-663-7674. " For affected units that were already implanted as of April 27, 2011, the patient booklet given to the patient may include information written by the physician or hospital staff that is related to the implanted system (ICD and leads), physician references and patient medications. For this reason and given the fact that the company determined that there is no risk for the patient associated with this labeling error, the company decided to not replace the patient booklet for this population.

Root cause

Error in labeling

Status

Terminated

Product code

MRM

Quantity affected

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.

Date initiated

2011-05-02

Date posted

2011-06-22

Date terminated

2012-04-26

Location

Plymouth, MN