Reported Jun 28, 2023 · Ongoing
CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; 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 DTBA2D4 VIVA XT IS1/DF4 INTLModel Number DTBA2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169217966
- Lot Serial Numbers
550 of 550 codes
BLI613233SBLI613324SBLI613699SBLI614038SBLI614165SBLI613293SBLI613712SBLI613772SBLI614301SBLI613871SBLI614140SBLI614826SBLI612567SBLI614031SBLI613259SBLI613417SBLI614737SBLI614194SBLI614210SBLI614604SBLI613371SBLI612853SBLI612859SBLI613234SBLI613304SBLI613305SBLI613994SBLI614312SBLI614469SBLI612711SBLI612774SBLI612954SBLI613449SBLI613588SBLI613591SBLI614002SBLI614013SBLI614290SBLI614537SBLI614600SBLI612805SBLI613296SBLI614202SBLI614460SBLI613765SBLI613867SBLI614307SBLI614462SBLI614482SBLI614593SBLI612754SBLI612627SBLI612707SBLI612922SBLI613008SBLI613255SBLI613312SBLI613592SBLI613665SBLI613874S
- Lot Serial Numbers
929 of 929 codes
BLI613497SBLI612633SBLI612639SBLI612814SBLI612816SBLI612818SBLI612474SBLI612565SBLI612624SBLI613054SBLI613064SBLI612544SBLI613408SBLI613062SBLI613365SBLI613542SBLI613547SBLI612618SBLI613363SBLI612562SBLI613069SBLI613083SBLI613530SBLI613725SBLI613410SBLI613548SBLI613559SBLI612513SBLI612663SBLI612541SBLI612550SBLI613082SBLI613072SBLI613074SBLI613075SBLI612712SBLI612713SBLI612450SBLI612469SBLI612509SBLI612171SBLI612496SBLI612534SBLI612482SBLI612484SBLI612490SBLI612580SBLI613353SBLI613376SBLI613057SBLI612630SBLI612641SBLI612645SBLI612696SBLI612697SBLI612455SBLI612756SBLI612634SBLI612637SBLI613090S
- Lot Serial Numbers
1,229 of 1,229 codes
BLI614334SBLI615844SBLI615933SBLI615914SBLI615913SBLI615677SBLI613817SBLI613572SBLI613521SBLI613429SBLI613433SBLI613629SBLI613811SBLI614493SBLI614435SBLI615158SBLI615489SBLI615413SBLI614623SBLI614989SBLI613509SBLI615062SBLI615067SBLI614682SBLI615328SBLI615523SBLI613625SBLI614495SBLI614559SBLI614614SBLI614627SBLI614928SBLI615202SBLI615412SBLI613950SBLI613887SBLI614339SBLI614490SBLI615129SBLI613427SBLI613431SBLI613807SBLI613808SBLI613568SBLI613569SBLI613508SBLI613565SBLI613566SBLI613890SBLI613891SBLI613893SBLI613894SBLI613895SBLI614418SBLI614878SBLI614879SBLI614882SBLI614883SBLI614886SBLI614887S
- Amount recalled
- 2904 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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