Z-0928-2013Class II

Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated...

Name: Z-0928-2013 Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated...
Creator: Sorin Group USA, Inc.
Published: 2013-01-28
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2013-01-28 / Terminated / root cause: design

FDA source

Sorin Group USA, Inc. began a recall of Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and... on 2013-01-28. FDA classified it as Class II and gives the reason as "Isoline defibrillation leads distributed may have internal insulation breach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0928-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-28
Posted: 2013-03-08
Terminated: 2015-12-09
Recalling firm: LivaNova USA, Inc.
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
Product code: MRM Defibrillator, Implantable, Dual-Chamber
Reason for recall: Isoline defibrillation leads distributed may have internal insulation breach.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1376 Isoline leads
Distribution: 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.
Product codes and lots: Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0928-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0928-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08

Product code MRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)