Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for lon

FDA device recall Z-0660-2016 · posted 2016-01-21 · Terminated

Recall details

Recalling firm

St Jude Medical Cardiac Rhythm Management Division

Reason for recall

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

Action taken

An Important Medical Device Advisory letter was sent to doctors on 11/3/15 to inform them of the recall by St. Jude Medical. The letter informs the doctors that St. Jude Medical identified that during the manufacturing process of a limited number of Optisure leads, a trim technique to remove excess medical adhesive around the SVC shock coil may have introduced damage to the leads insulation. The letter provides the doctors with the recommendations for patients with a potentially impacted Optisure lead connected to a device with Dynamic TX technology and for patients implanted with a potentially impacted Optisure lead connected to a device without DynamicTx technology. Doctors with questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at (800) 722-3774. A revised dear doctor letter was sent via FedEx on 1/21/16 to all affected physicians. A press release will be sent/posted on 1/22/16.

Root cause

Process control

Status

Terminated

Product code

LWS

Quantity 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.

Date initiated

2015-11-03

Date posted

2016-01-21

Date terminated

2019-05-10

Location

Sylmar, CA