St Jude Medical Cardiac Rhythm Management Division recalls Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical.

Recalled January 27, 2016 · FDA recall Z-0660-2016 · St Jude Medical Cardiac Rhythm Management Division

Hazard

Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil. · FDA Class I

Units

447 units total (281 units in US)

Sold at

Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.

Description

Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.

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).

Manufacturer(s)

St Jude Medical Cardiac Rhythm Management Division

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →