Recall Z-0660-2016— St Jude Medical Cardiac Rhythm Management Division
Class I · Terminated
Class I FDA medical device recall by St Jude Medical Cardiac Rhythm Management Division, initiated 2015-11-03, terminated 2019-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil..
- Recalling firm
- St Jude Medical Cardiac Rhythm Management Division
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-11-03
- Terminated
- 2019-05-10
- Firm location
- Sylmar, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.