FDA Medical Device Recalls (openFDA)
Sorin Group USA, Inc.: 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
- Recall number
- Z-0928-2013
- Recalling firm
- Sorin Group 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
- Status
- Terminated
- Initiated
- 2013-01-28
- Posted
- 2013-03-08
- Terminated
- 2015-12-09
- Reason
- Isoline defibrillation leads distributed may have internal insulation breach.
- 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
- 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.
- Lot, serial or model codes
- Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
- 510(k) numbers
- not on file
- PMA numbers
- ["P980049S021","P980049S024"]
- Product code
- MRM
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28