Reported Jun 28, 2023 · Ongoing
CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; 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?
CRT-D DTBC2D4 BRAVA IS1/DF4 INTLModel Number DTBC2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720305
- Lot Serial Numbers
587 of 587 codes
BLZ604044SBLZ604109SBLZ603698SBLZ603713SBLZ603726SBLZ603835SBLZ604013SBLZ604101SBLZ603725SBLZ604036SBLZ604059SBLZ603770SBLZ604032SBLZ603602SBLZ603626SBLZ604001SBLZ603743SBLZ604536SBLZ603622SBLZ604076SBLZ604915SBLZ604263SBLZ603735SBLZ603422SBLZ603918SBLZ604138SBLZ603587SBLZ603604SBLZ603663SBLZ603723SBLZ603840SBLZ604082SBLZ604065SBLZ604080SBLZ604102SBLZ603740SBLZ603967SBLZ604467SBLZ603620SBLZ603705SBLZ603788SBLZ603812SBLZ603977SBLZ603978SBLZ603980SBLZ604031SBLZ604072SBLZ604134SBLZ604097SBLZ603639SBLZ603941SBLZ604056SBLZ603594SBLZ603683SBLZ603720SBLZ603898SBLZ603921SBLZ603982SBLZ603983SBLZ604057S
- Lot Serial Numbers
2,124 of 2,124 codes
BLZ605132SBLZ606613SBLZ605721SBLZ605800SBLZ604184SBLZ606515SBLZ606516SBLZ604345SBLZ605081SBLZ606068SBLZ606219SBLZ604926SBLZ604540SBLZ604178SBLZ605314SBLZ606061SBLZ605126SBLZ604561SBLZ604859SBLZ605114SBLZ604814SBLZ604923SBLZ604515SBLZ605309SBLZ604275SBLZ604743SBLZ605414SBLZ604781SBLZ604230SBLZ604358SBLZ604487SBLZ604582SBLZ604976SBLZ604983SBLZ605096SBLZ605121SBLZ605241SBLZ605330SBLZ605359SBLZ605600SBLZ605619SBLZ606108SBLZ605082SBLZ605747SBLZ604400SBLZ604649SBLZ605394SBLZ605424SBLZ606166SBLZ604361SBLZ604392SBLZ604428SBLZ605257SBLZ605260SBLZ605698SBLZ605192SBLZ605211SBLZ605851SBLZ604405SBLZ604661S
- Amount recalled
- 3355 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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