Reported Jun 28, 2023 · Ongoing
CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; 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 DTBC2D1 BRAVA IS1/DF1 INTLModel Number DTBC2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720367
- Lot Serial Numbers
1,201 of 1,201 codes
BLW607464SBLW607601SBLW607643SBLW607705SBLW607921SBLW608132SBLW608133SBLW608134SBLW608135SBLW608235SBLW608746SBLW609769SBLW606989SBLW607809SBLW607902SBLW607917SBLW607284SBLW607004SBLW607851SBLW607173SBLW607320SBLW607015SBLW607319SBLW607257SBLW607269SBLW607346SBLW607361SBLW607031SBLW607243SBLW606959SBLW607058SBLW607285SBLW607580SBLW607394SBLW607249SBLW607505SBLW607573SBLW606999SBLW607254SBLW607835SBLW607159SBLW606948SBLW606961SBLW607044SBLW607113SBLW607292SBLW607406SBLW607498SBLW607661SBLW607758SBLW607759SBLW607865SBLW607248SBLW607866SBLW607021SBLW607598SBLW607665SBLW607823SBLW607493SBLW607001S
- Lot Serial Numbers
1,510 of 1,510 codes
BLW610806SBLW613813SBLW615082SBLW615321SBLW608105SBLW608252SBLW608748SBLW608829SBLW608867SBLW609063SBLW609247SBLW609264SBLW609355SBLW609665SBLW610234SBLW610622SBLW610850SBLW610904SBLW612442SBLW612659SBLW613241SBLW613702SBLW614591SBLW608994SBLW610886SBLW608168SBLW608170SBLW608399SBLW608557SBLW608560SBLW608949SBLW608051SBLW608298SBLW608530SBLW608983SBLW608563SBLW608616SBLW608938SBLW608527SBLW609080SBLW610214SBLW608846SBLW607957SBLW607960SBLW608174SBLW608388SBLW608836SBLW609718SBLW608213SBLW609904SBLW608265SBLW608474SBLW608647SBLW608153SBLW608643SBLW609856SBLW608486SBLW608140SBLW608262SBLW608479S
- Amount recalled
- 7921 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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