Reported Jun 28, 2023 · Ongoing
CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; 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?
CRTD DTMC1QQ COMPIA MRI QUAD US DF4Model Number DTMC1QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720749
- Lot Serial Numbers
1,426 of 1,426 codes
RPL202320HRPL202797HRPL202825HRPL203304HRPL203279HRPL203319HRPL203730HRPL203754HRPL204075HRPL202479HRPL202565HRPL202842HRPL203342HRPL203518HRPL203521HRPL203522HRPL203534HRPL203543HRPL203556HRPL203602HRPL203718HRPL203723HRPL203785HRPL203210HRPL202222HRPL202318HRPL202555HRPL202697HRPL202831HRPL203172HRPL202156HRPL202223HRPL202514HRPL203290HRPL203308HRPL203446HRPL202803HRPL202347HRPL202465HRPL202684HRPL202688HRPL202707HRPL202934HRPL202972HRPL203031HRPL203078HRPL203345HRPL203399HRPL203581HRPL203623HRPL203688HRPL202382HRPL202497HRPL202590HRPL203217HRPL203225HRPL203363HRPL203369HRPL203428HRPL203479H
- Lot Serial Numbers
1,094 of 1,094 codes
RPL600197SRPL600133SRPL600239SRPL600048SRPL600051SRPL600141SRPL601305SRPL600952SRPL601106SRPL601107SRPL601159SRPL600047SRPL600050SRPL600098SRPL600440SRPL600512SRPL600530SRPL600580SRPL600585SRPL600661SRPL600706SRPL600709SRPL601206SRPL601199SRPL601204SRPL600176SRPL600189SRPL600426SRPL600633SRPL600859SRPL601339SRPL601340SRPL600980SRPL600631SRPL601136SRPL601152SRPL601153SRPL601182SRPL601183SRPL601178SRPL601155SRPL601156SRPL600726SRPL601061SRPL601067SRPL601077SRPL601275SRPL600852SRPL600854SRPL600863SRPL600054SRPL600079SRPL600172SRPL600179SRPL600181SRPL600186SRPL600230SRPL600232SRPL600320SRPL600355S
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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