Reported Jun 28, 2023 · Ongoing
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; 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-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INTModel Number DDMB2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169443419
- Lot Serial Numbers
2,714 of 2,714 codes
PGZ624363SPGZ631078SPGZ638449SPGZ638465SPGZ623851SPGZ645877SPGZ621671SPGZ621673SPGZ623094SPGZ623561SPGZ623984SPGZ623985SPGZ623986SPGZ623991SPGZ624447SPGZ626933SPGZ626995SPGZ627005SPGZ627071SPGZ629198SPGZ629204SPGZ629217SPGZ631034SPGZ631035SPGZ631036SPGZ631037SPGZ633073SPGZ633357SPGZ633680SPGZ635203SPGZ635731SPGZ635749SPGZ635812SPGZ635815SPGZ635820SPGZ637440SPGZ637885SPGZ637919SPGZ637947SPGZ637950SPGZ638090SPGZ638096SPGZ638463SPGZ641070SPGZ641071SPGZ641072SPGZ641083SPGZ641140SPGZ641168SPGZ641651SPGZ641687SPGZ642430SPGZ643962SPGZ645328SPGZ622752SPGZ626967SPGZ629552SPGZ630964SPGZ631210SPGZ632646S
- Amount recalled
- 35,961 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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