Reported Jun 28, 2023 · Ongoing
CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; 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 DTMB1D4 AMPLIA MRI US DF4Model Number DTMB1D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720718
- Lot Serial Numbers
1,158 of 1,158 codes
RPJ204877HRPJ205009HRPJ205996HRPJ206294HRPJ205851HRPJ206501HRPJ205969HRPJ205051HRPJ206429HRPJ205893HRPJ205344HRPJ206237HRPJ206208HRPJ206032HRPJ206082HRPJ206104HRPJ205080HRPJ205234HRPJ206059HRPJ205438HRPJ206376HRPJ205287HRPJ205509HRPJ206342HRPJ205891HRPJ204872HRPJ204899HRPJ204933HRPJ204973HRPJ205142HRPJ205777HRPJ205989HRPJ206295HRPJ205059HRPJ205148HRPJ205732HRPJ205873HRPJ206504HRPJ205500HRPJ206357HRPJ204876HRPJ206359HRPJ206369HRPJ205623HRPJ206218HRPJ205743HRPJ206172HRPJ204917HRPJ205981HRPJ205041HRPJ205073HRPJ205235HRPJ205246HRPJ205279HRPJ206045HRPJ205880HRPJ206050HRPJ206207HRPJ205049HRPJ204888H
- Lot Serial Numbers
1,553 of 1,553 codes
RPJ601555SRPJ601599SRPJ601649SRPJ600734SRPJ601458SRPJ601526SRPJ601520SRPJ601638SRPJ601642SRPJ601172SRPJ601273SRPJ602085SRPJ601218SRPJ601351SRPJ601296SRPJ601501SRPJ601843SRPJ602037SRPJ601230SRPJ601265SRPJ601272SRPJ601367SRPJ601380SRPJ601384SRPJ601389SRPJ601617SRPJ602036SRPJ602171SRPJ600687SRPJ601586SRPJ600429SRPJ600565SRPJ600036SRPJ601840SRPJ600499SRPJ602091SRPJ601305SRPJ600597SRPJ600688SRPJ600714SRPJ601040SRPJ601041SRPJ600556SRPJ600743SRPJ601342SRPJ601364SRPJ601425SRPJ601979SRPJ600407SRPJ601761SRPJ601418SRPJ600033SRPJ600697SRPJ601574SRPJ601722SRPJ601727SRPJ600443SRPJ600465SRPJ600955SRPJ601031S
- Amount recalled
- 2767 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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