FDA Device recall Z-0660-2016
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical
- FDA Device
- Class I
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class I recall of Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical by St Jude Medical Cardiac Rhythm Management Division, citing leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0660-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-11-03 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical Cardiac Rhythm Management Division |
| Distribution | US |
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.
Identifiers
| code_info | BRE010002 BRE010016 BRE010032 BRE010033 BRE010034 BRE010035 BRE010037 BRE010039 BRE010040 BRE010042 BRE010044…BRE010002 BRE010016 BRE010032 BRE010033 BRE010034 BRE010035 BRE010037 BRE010039 BRE010040 BRE010042 BRE010044 BRE010046 BRE010062 BRE010066 BRE010075 BRE010077 BRE010082 BRE010096 BRE010097 BRE010098 BRE010099 BRE010165 BRE010166 BRE010173 BRE010183 BRE010185 BRE010191 BRE010194 BRE010195 BRE010205 BRE010208 BRE010215 BRE010220 BRE010226 BRE010232 BRE010235 BRE010240 BRE010241 BRE010258 BRE010299 BRE013300 BRE013302 BRG010102 BRG010103 BRG010116 BRG010174 BRG010178 BRG010179 BRG010188 BRG010205 BRG010206 BRG010207 BRG010213 BRG010232 BRG010233 BRG010237 BRG010238 BRG010246 BRG010247 BRG010248 BRG010249 BRG010250 BRG010264 BRG010285 BRG010298 BRG010350 BRG010383 BRG010396 BRG010404 BRG010405 BRG010411 BRG010415 BRG010574 BRG010619 BRG010625 BRG010658 BRG010664 BRG010684 BRG010721 BRG010722 BRG010723 BRG010770 BRG010812 BRG010814 BRG010818 BRG010820 BRG010821 BRG010822 BRG010937 BRG010938 BRG010939 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0660-2016%22
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