—#115895

Product

Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias

FDA product code: MRM — Defibrillator, Implantable, Dual-Chamber
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P980049S021, P980049S024
Affected lot / code info: Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13

Why it was recalled

Isoline defibrillation leads distributed may have internal insulation breach.

Root cause (FDA determination)

Device Design

Action the firm took

Sorin C.R.M., srl sent an Urgent Medical Device Field Safety Notice dated January28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return any unused products by certified mail with signed acknowledgment form, patients should continue to be monitored by their physician field reps during notification visit, and customers should make sure all personnel involved in the management of patients implanted with affected product are aware of the information described in the Field Safety Notice. Customers with questions should contact their local Sorin representative at 1-610-304-9728. For questions regarding this recall call 303-467-6222.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004

Distribution

Distribution pattern: Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom.

Timeline

Recall initiated: 2013-01-28
Posted by FDA: 2013-03-08
Terminated: 2015-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115895. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.