Reported Jun 28, 2023 · Ongoing
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; 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 COBALT HF MRI IS1 DF1Model Number DTPB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178222
- Lot Serial numbers
2,607 of 2,607 codes
RTP600502SRTP602448SRTP600549SRTP600551SRTP600553SRTP600554SRTP600555SRTP601566SRTP601569SRTP602731SRTP602733SRTP601785SRTP601786SRTP601825SRTP601826SRTP601620SRTP602203SRTP602327SRTP600744SRTP600745SRTP600762SRTP601117SRTP601187SRTP601231SRTP601906SRTP603519SRTP600475SRTP600228SRTP600308SRTP600757SRTP601116SRTP601219SRTP601221SRTP601723SRTP601724SRTP601907SRTP602117SRTP602216SRTP601572SRTP602154SRTP602038SRTP600454SRTP600670SRTP601041SRTP601066SRTP601209SRTP601801SRTP600394SRTP600397SRTP600184SRTP601049SRTP601072SRTP601822SRTP600645SRTP603289SRTP603604SRTP600559SRTP600796SRTP601834SRTP600396S
- Lot Serial Numbers
104 of 104 codes
RTP602975SRTP602991SRTP602987SRTP602989SRTP603706SRTP603089SRTP602527SRTP602530SRTP603005SRTP603070SRTP603299SRTP601483SRTP601462SRTP603129SRTP600318SRTP600325SRTP602976SRTP603123SRTP600265SRTP603108SRTP603291SRTP603684SRTP600337SRTP601398SRTP602660SRTP603166SRTP600037SRTP602802SRTP601443SRTP602807SRTP602978SRTP603017SRTP603675SRTP601459SRTP603133SRTP601516SRTP602842SRTP603665SRTP601467SRTP602968SRTP602974SRTP603025SRTP603145SRTP601464SRTP602671SRTP603095SRTP603564SRTP603686SRTP602792SRTP602953SRTP601514SRTP603029SRTP603560SRTP603152SRTP603138SRTP602659SRTP601374SRTP600032SRTP602799SRTP601375S
- Amount recalled
- 2884 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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