Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
Reported: January 27, 2016 Initiated: November 3, 2015 #Z-0660-2016
Product Description
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
Reason for Recall
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Details
- Recalling Firm
- St Jude Medical Cardiac Rhythm Management Division
- Units Affected
- 447 units total (281 units in US)
- Distribution
- Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.
- Location
- Sylmar, CA
Frequently Asked Questions
What product was recalled? ▼
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).. Recalled by St Jude Medical Cardiac Rhythm Management Division. Units affected: 447 units total (281 units in US).
Why was this product recalled? ▼
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2016. Severity: Critical. Recall number: Z-0660-2016.
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