Reported Jun 28, 2023 · Ongoing
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; 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 DTBB1QQ VIVA QUAD S IS4/DF4 USModel Number DTBB1QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720145
- Lot Serial Numbers
193 of 193 codes
BLK205268HBLK205272HBLK205461HBLK205544HBLK205582HBLK205328HBLK205358HBLK205475HBLK205492HBLK205304HBLK205346HBLK205364HBLK205269HBLK205352HBLK205349HBLK205400HBLK205432HBLK205451HBLK205309HBLK205310HBLK205315HBLK205514HBLK205424HBLK205466HBLK205513HBLK205279HBLK205504HBLK205314HBLK205376HBLK205377HBLK205394HBLK205443HBLK205444HBLK205275HBLK205284HBLK205285HBLK205287HBLK205298HBLK205312HBLK205379HBLK205389HBLK205406HBLK205415HBLK205419HBLK205429HBLK205431HBLK205435HBLK205464HBLK205471HBLK205478HBLK205512HBLK205517HBLK205524HBLK205528HBLK205541HBLK205427HBLK205289HBLK205387HBLK205566HBLK205374H
- Amount recalled
- 193 units
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.