Recall Z-0660-2016 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
St Jude Medical Cardiac Rhythm Management Division
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).
| Date | Jan 21, 2016 (initiated Nov 3, 2015) |
| Status | Terminated |
| Reason | Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil. |
| Root cause | Process control |
| Action | 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 potentia |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.