Reported Jun 28, 2023 · Ongoing
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 USModel Number DTBB1Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720206
- Lot Serial Numbers
123 of 123 codes
BLM202912HBLM203000HBLM202895HBLM202965HBLM203007HBLM203028HBLM203031HBLM203063HBLM202844HBLM202900HBLM203042HBLM203014HBLM203015HBLM203062HBLM202811HBLM202838HBLM202857HBLM202858HBLM202881HBLM202923HBLM203001HBLM203021HBLM202848HBLM202878HBLM202827HBLM202952HBLM203061HBLM202909HBLM202921HBLM202942HBLM202830HBLM202850HBLM202886HBLM202888HBLM202829HBLM202911HBLM202958HBLM202982HBLM203037HBLM202945HBLM202929HBLM202949HBLM202973HBLM202828HBLM202990HBLM202947HBLM202960HBLM202854HBLM202944HBLM202810HBLM202847HBLM202862HBLM202880HBLM202904HBLM202946HBLM202974HBLM202979HBLM203006HBLM203012HBLM203040H
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
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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