Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for...
⚠ Critical Alert — Stop Using Immediately
This product has been flagged with severe risks (electrical shock). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0660-2016.
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0660-2016.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact St Jude Medical Cardiac Rhythm Management Division or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0660-2016.
St Jude Medical Cardiac Rhythm Management Division
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
St Jude Medical Cardiac Rhythm Management Division Recall FAQ
St Jude Medical Cardiac Rhythm Management Division is the subject of a medical implants safety report: Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for.... The notice was published on November 3, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 447 units are potentially affected.