Reported Jun 28, 2023 · Ongoing
CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; 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 QUAD MRI IS4 DF1Model Number DTPB2Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178185
- Lot Serial Numbers
1,716 of 1,716 codes
RTL600234SRTL600470SRTL601046SRTL601412SRTL601722SRTL601669SRTL601698SRTL600323SRTL600660SRTL600661SRTL601185SRTL601206SRTL601213SRTL601406SRTL601445SRTL601446SRTL600649SRTL600650SRTL601428SRTL601017SRTL600219SRTL601076SRTL601544SRTL602514SRTL600684SRTL601477SRTL601865SRTL600638SRTL600639SRTL600640SRTL600641SRTL600642SRTL600643SRTL601151SRTL601154SRTL601156SRTL601160SRTL601161SRTL601162SRTL601163SRTL601164SRTL601165SRTL601167SRTL601170SRTL600209SRTL600835SRTL600997SRTL600519SRTL601459SRTL601689SRTL600978SRTL601540SRTL601880SRTL600522SRTL601510SRTL600949SRTL601624SRTL601372SRTL600810SRTL600266S
- Lot Serial numbers
163 of 163 codes
RTL600040SRTL602020SRTL602180SRTL602548SRTL600014SRTL601004SRTL602177SRTL602186SRTL602171SRTL601756SRTL601983SRTL601499SRTL601018SRTL602003SRTL602008SRTL602441SRTL600036SRTL600984SRTL601504SRTL601578SRTL600037SRTL601447SRTL601645SRTL601757SRTL602193SRTL602004SRTL602191SRTL602443SRTL600022SRTL600032SRTL601522SRTL601539SRTL600071SRTL601505SRTL602429SRTL601744SRTL601966SRTL600074SRTL600076SRTL602109SRTL602360SRTL602396SRTL602435SRTL602460SRTL600023SRTL601637SRTL602043SRTL602535SRTL601742SRTL600007SRTL601043SRTL602187SRTL601047SRTL600970SRTL600044SRTL601633SRTL600038SRTL600042SRTL600043SRTL600050S
- Amount recalled
- 1878 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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