Reported Jun 28, 2023 · Ongoing
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; 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 DTBB2D4 VIVA S IS1/DF4 INTLModel Number DTBB2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
61 of 61 codes
GTIN 00643169720299Lot Serial NumbersBLR602282SBLR602271SBLR602274SBLR602363SBLR602366SBLR602278SBLR602289SBLR602365SBLR602238SBLR602293SBLR602325SBLR602332SBLR602333SBLR602334SBLR602336SBLR602337SBLR602340SBLR602353SBLR602360SBLR602361SBLR602356SBLR602236SBLR602237SBLR602290SBLR602296SBLR602306SBLR602338SBLR602341SBLR602358SBLR602378SBLR602335SBLR602339SBLR602359SBLR602308SBLR602328SBLR602330SBLR602331SBLR602352SBLR602357SBLR602390SBLR602269SBLR602381SBLR602382SBLR602383SBLR602384SBLR602387SBLR602398SBLR602394SBLR602395SBLR602385SBLR602386SBLR602388SBLR602397SBLR602379SBLR602380SBLR602389SBLR602362SBLR602377S
- Lot Serial Numbers
368 of 368 codes
BLR602821SBLR602777SBLR602490SBLR602342SBLR602492SBLR602425SBLR602408SBLR602430SBLR602515SBLR602516SBLR602518SBLR602520SBLR602530SBLR602531SBLR602534SBLR602535SBLR602537SBLR602540SBLR602542SBLR602544SBLR602545SBLR602546SBLR602548SBLR602550SBLR602552SBLR602554SBLR602555SBLR602587SBLR602632SBLR602633SBLR602638SBLR602639SBLR602640SBLR602644SBLR602645SBLR602647SBLR602669SBLR602670SBLR602672SBLR602682SBLR602710SBLR602711SBLR602751SBLR602752SBLR602753SBLR602754SBLR602760SBLR602763SBLR602770SBLR602773SBLR602787SBLR602788SBLR602789SBLR602790SBLR602791SBLR602792SBLR602793SBLR602794SBLR602795SBLR602796S
- Lot Serial Numbers
BLR602824SBLR602825SBLR602826SBLR602830SBLR602831SBLR602832SBLR602833SBLR602834SBLR602835SBLR602836S
- Amount recalled
- 435 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.
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