Sorin Isoline Implantable Defibrillation Leads Recalled for Insulation Breach
Sorin Group USA is recalling 1,376 Isoline implantable defibrillation leads due to potential internal insulation breaches. The leads are used for treating life-threatening heart arrhythmias.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the product is a life-sustaining medical device (defibrillator lead) where an insulation breach poses a significant risk of serious injury or death if the device fails to treat a life-threatening arrhythmia.
Plain-English summary
Sorin Group USA, Inc. is recalling 1,376 Isoline Implantable Defibrillation Leads, specifically models 2CR5, 2CR6, and 2CT6. These medical devices are indicated for ventricular antitachycardia pacing and ventricular defibrillation to automatically treat life-threatening arrhythmias.
The recall was initiated because the distributed leads may have an internal insulation breach. This defect could potentially compromise the safety and effectiveness of the device in treating cardiac conditions.
The affected leads were distributed worldwide, including nationwide in the United States and to numerous international markets such as Argentina, Australia, Canada, and the United Kingdom. The distribution period for these specific models ranged from March 19, 2008, to January 21, 2013. Patients with these implanted devices should contact their healthcare providers to discuss the recall and determine if any action is necessary.
The recalled product
- 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
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 1,376
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Models: 2CR5
- 2CR6 and 2CT6
- Distributed From 03/19/08 To 01/21/13
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Sorin Group USA, Inc.
See all →- HighSorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
- HighSorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
Same hazard · insulation breach
See all →- SevereMegadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach
FDA (Devices) · 2013-09-04