Reported Jun 28, 2023 · Ongoing
ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; 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?
ICD COBALT XT DR MRI IS1 DF1Model Number DDPA2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178338
- Lot Serial Numbers
1,663 of 1,663 codes
RSL602442SRSL601336SRSL600186SRSL602060SRSL601499SRSL601501SRSL602893SRSL602901SRSL602941SRSL602955SRSL602420SRSL602899SRSL601490SRSL602690SRSL600167SRSL600499SRSL600561SRSL600563SRSL600564SRSL600565SRSL601867SRSL601868SRSL601870SRSL601966SRSL603729SRSL601838SRSL602889SRSL600163SRSL602444SRSL602823SRSL602826SRSL603092SRSL603105SRSL603233SRSL603237SRSL603565SRSL600206SRSL600230SRSL600231SRSL601723SRSL601789SRSL601878SRSL602705SRSL602854SRSL602828SRSL602933SRSL603236SRSL601484SRSL601988SRSL603618SRSL602324SRSL602979SRSL603759SRSL600237SRSL601990SRSL600172SRSL602465SRSL602466SRSL602467SRSL602468S
- Lot Numbers
510 of 510 codes
RSL601023SRSL603552SRSL603892SRSL603508SRSL603540SRSL603078SRSL602605SRSL603572SRSL602734SRSL602572SRSL602601SRSL603564SRSL603113SRSL602990SRSL601925SRSL601568SRSL600958SRSL602567SRSL602604SRSL601207SRSL601274SRSL601465SRSL601206SRSL601208SRSL601483SRSL601471SRSL602090SRSL602649SRSL602651SRSL601264SRSL601460SRSL601594SRSL600107SRSL600124SRSL602996SRSL602985SRSL603364SRSL603463SRSL603472SRSL600874SRSL600875SRSL600878SRSL600906SRSL601081SRSL601889SRSL601898SRSL601899SRSL601919SRSL600884SRSL601007SRSL601408SRSL602410SRSL602411SRSL602776SRSL602780SRSL602759SRSL602664SRSL603110SRSL603112SRSL603492S
- Lot Numbers
537 of 537 codes
RSL600852SRSL601395SRSL600476SRSL600942SRSL601205SRSL601247SRSL602140SRSL602326SRSL602646SRSL603399SRSL603506SRSL603528SRSL603530SRSL602094SRSL603787SRSL600144SRSL602668SRSL600775SRSL600885SRSL602325SRSL603350SRSL600841SRSL600969SRSL601575SRSL602945SRSL601073SRSL602361SRSL603499SRSL602146SRSL602947SRSL603348SRSL600774SRSL600890SRSL603345SRSL602384SRSL602387SRSL602727SRSL603037SRSL603043SRSL603324SRSL603511SRSL603044SRSL603325SRSL603512SRSL603470SRSL600731SRSL600748SRSL600899SRSL600941SRSL601252SRSL601396SRSL602172SRSL603028SRSL603054SRSL602123SRSL602142SRSL600796SRSL601221SRSL602314SRSL602681S
- Amount recalled
- 2748 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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