FDAFDA · Food and drugs·Recall number Z-1486-2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
Published August 17, 2022 · Recall initiated: June 22, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- Worldwide Distribution
- Lot
- a. Model Numbers: DTPA2D4: GTIN 00763000178130, Serial Numbers: RTG600136S, RTG600270S, RTG601323S, RTG601338S, RTG601367S, RTG601433S, RTG601484S, RTG601489S, RTG601575S, RTG601583S, RTG601595S, RTG601632S, RTG601643S, RTG601653S, RTG601657S, RTG601669S, RTG601775S, RTG601790S, RTG601802S, RTG601805S, RTG601820S, RTG601847S, RTG601892S, RTG601904S, RTG601968S, RTG602017S, RTG602019S, RTG602125S, RTG602147S, RTG602179S, RTG602182S, RTG602191S, RTG602207S, RTG602209S, RTG602221S, RTG602226S, RTG602238S, RTG602239S, RTG602360S, RTG602439S, RTG602477S, RTG602480S, RTG602490S, RTG602506S, RTG602512S, RTG602515S, RTG602516S, RTG602524S, RTG602550S, RTG602580S, RTG602584S; GTIN 00763000178154, Serial Numbers: RTG600028S, RTG600029S, RTG600030S, RTG600033S, RTG600036S, RTG600037S, RTG600040S, RTG600048S, RTG600049S, RTG600054S, RTG600055S, RTG600056S, RTG600059S, RTG600060S, RTG600061S, RTG600062S, RTG600063S, RTG600064S, RTG600065S, RTG600066S, RTG600067S, RTG600068S, RTG600069S, RTG600070S, RTG600071S, RTG600072S, RTG600073S, RTG600074S, RTG600075S, RTG600076S, RTG600077S, RTG600079S, RTG600081S, RTG600082S, RTG600083S, RTG600085S, RTG600086S, RTG600087S, RTG600089S, RTG600090S, RTG600091S, RTG600092S, RTG600095S, RTG600096S, RTG600097S, RTG600098S, RTG600099S, RTG600100S, RTG600101S, RTG600104S, RTG600105S, RTG600106S, RTG600107S, RTG600108S, RTG600110S, RTG600111S, RTG600112S, RTG600113S, RTG600114S, RTG600115S, RTG600116S, RTG600117S, RTG600118S, RTG600119S, RTG600120S, RTG600124S, RTG600126S, RTG600146S, RTG600256S, RTG600268S, RTG600294S, RTG600310S, RTG600341S, RTG600345S, RTG600346S, RTG600348S, RTG600352S, RTG600356S, RTG600363S, RTG600366S, RTG600367S, RTG600375S, RTG600377S, RTG600378S, RTG600388S, RTG600390S, RTG600393S, RTG600395S, RTG600405S, RTG600415S, RTG600455S, RTG600462S, RTG600468S, RTG600469S, RTG600474S, RTG600486S, RTG600491S, RTG600523S, RTG600525S, RTG600531S, RTG600534S, RTG600537S, RTG600538S, RTG600540S, RTG600546S, RTG600602S, RTG600670S, RTG600671S, RTG600672S, RTG600673S, RTG600674S, RTG600675S, RTG600676S, RTG600677S, RTG600678S, RTG600679S, RTG600757S, RTG600760S, RTG600772S, RTG600773S, RTG600774S, RTG600780S, RTG600782S, RTG600783S, RTG600784S, RTG600787S, RTG600794S, RTG600795S, RTG600796S, RTG600798S, RTG600800S, RTG600801S, RTG600803S, RTG600805S, RTG600808S, RTG600809S, RTG600810S, RTG600811S, RTG600812S, RTG600813S, RTG600817S, RTG600819S, RTG600821S, RTG600834S, RTG600837S, RTG600838S, RTG600839S, RTG600840S, RTG600842S, RTG600843S, RTG600844S, RTG600846S, RTG600848S, RTG600849S, RTG600850S, RTG600851S, RTG600853S, RTG600854S, RTG600855S, RTG600856S, RTG600857S, RTG600858S, RTG600859S, RTG600860S, RTG600862S, RTG600863S, RTG600864S, RTG600865S, RTG600866S, RTG600867S, RTG600869S, RTG600871S, RTG600872S, RTG600873S, RTG600874S, RTG600876S, RTG600877S, RTG600878S, RTG600879S, RTG600880S, RTG600881S, RTG600882S, RTG600883S, RTG600884S, RTG600885S, RTG600887S, RTG600888S, RTG600889S, RTG600890S, RTG600891S, RTG600892S, RTG600893S, RTG600894S, RTG600895S, RTG600896S, RTG600897S, RTG600898S, RTG600900S, RTG600901S, RTG600902S, RTG600903S, RTG600904S, RTG600905S, RTG600906S, RTG600907S, RTG600908S, RTG600909S, RTG600910S, RTG600911S, RTG600912S, RTG600913S, RTG600914S, RTG600915S, RTG600916S, RTG600917S, RTG600918S, RTG600919S, RTG600920S, RTG600921S, RTG600922S, RTG600923S, RTG600924S, RTG600925S, RTG600926S, RTG600927S, RTG600928S, RTG600929S, RTG600930S, RTG600932S, RTG600933S, RTG600936S, RTG600939S, RTG600940S, RTG600941S, RTG600942S, RTG600943S, RTG600944S, RTG600945S, RTG600946S, RTG600947S, RTG600948S, RTG600949S, RTG600951S, RTG600952S, RTG600953S, RTG600955S, RTG600956S, RTG600957S, RTG600958S, RTG600959S, RTG600960S, RTG600961S, RTG600962S, RTG600963S, RTG600964S, RTG600965S, RTG600966S, RTG600967S, RTG600968S, RTG600969S, RTG600970S, RTG600971S, RTG600972S, RTG600973S, RTG600974S, RTG600975S, RTG600976S, RTG600977S, RTG600978S, RTG600979S, RTG600980S, RTG600981S, RTG600982S, RTG
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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