Reported Jan 27, 2016 · Terminated
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for…
St Jude Medical Cardiac Rhythm Management Division
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St Jude Medical Cardiac Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- 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).
- Lot codes and dates
447 of 447 codes
BRE010002BRE010016BRE010032BRE010033BRE010034BRE010035BRE010037BRE010039BRE010040BRE010042BRE010044BRE010046BRE010062BRE010066BRE010075BRE010077BRE010082BRE010096BRE010097BRE010098BRE010099BRE010165BRE010166BRE010173BRE010183BRE010185BRE010191BRE010194BRE010195BRE010205BRE010208BRE010215BRE010220BRE010226BRE010232BRE010235BRE010240BRE010241BRE010258BRE010299BRE013300BRE013302BRG010102BRG010103BRG010116BRG010174BRG010178BRG010179BRG010188BRG010205BRG010206BRG010207BRG010213BRG010232BRG010233BRG010237BRG010238BRG010246BRG010247BRG010248
- Amount recalled
- 447 units total (281 units in US)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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