Reported Jun 28, 2023 · Ongoing
CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; 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 DTMB1D1 AMPLIA MRI US DF1Model Number DTMB1D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837690
- Lot Serial Numbers
1,444 of 1,444 codes
RPV203851HRPV203879HRPV204192HRPV204308HRPV205279HRPV205423HRPV205665HRPV205443HRPV205510HRPV204476HRPV205107HRPV204152HRPV204326HRPV204327HRPV204329HRPV203937HRPV204831HRPV204911HRPV205343HRPV205351HRPV205497HRPV205762HRPV205763HRPV205785HRPV203840HRPV204908HRPV205661HRPV203773HRPV203795HRPV203808HRPV204568HRPV205383HRPV205713HRPV205312HRPV205849HRPV204239HRPV205251HRPV203909HRPV204821HRPV205370HRPV205812HRPV205832HRPV205093HRPV204730HRPV204741HRPV204553HRPV203983HRPV205414HRPV205597HRPV205682HRPV205541HRPV204597HRPV204711HRPV205219HRPV205645HRPV205215HRPV205056HRPV203988HRPV204130HRPV204198H
- Lot Serial Numbers
1,267 of 1,267 codes
RPV601936SRPV601530SRPV601840SRPV601064SRPV601250SRPV600322SRPV600448SRPV600532SRPV600706SRPV600790SRPV600829SRPV600983SRPV601276SRPV600436SRPV600563SRPV601146SRPV601406SRPV601430SRPV601518SRPV601549SRPV600617SRPV600650SRPV601102SRPV601147SRPV601667SRPV601767SRPV601213SRPV601701SRPV601702SRPV601527SRPV601546SRPV601601SRPV601624SRPV601686SRPV601937SRPV600027SRPV600739SRPV601275SRPV601314SRPV601388SRPV601957SRPV600272SRPV600039SRPV600222SRPV600343SRPV600353SRPV600638SRPV600746SRPV601294SRPV601193SRPV600701SRPV600703SRPV600182SRPV600959SRPV601403SRPV601347SRPV601320SRPV601370SRPV600258SRPV600755S
- Amount recalled
- 3005 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.
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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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