FDAFDA · Food and drugs·Recall number Z-1773-2023
CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
Published June 28, 2023 · Recall initiated: May 10, 2023
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 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- US Nationwide - Worldwide Distribution
- Lot
- GTIN 00643169720688, Lot Serial numbers: RPF622750S, RPF618290S, RPF616459S, RPF619209S, RPF620414S, RPF613519S, RPF617908S, RPF607263S, RPF605123S, RPF606355S, RPF607965S, RPF607966S, RPF607968S, RPF607969S, RPF610837S, RPF612639S, RPF613175S, RPF613176S, RPF614678S, RPF616130S, RPF616164S, RPF616174S, RPF616577S, RPF616578S, RPF617220S, RPF617584S, RPF617585S, RPF617586S, RPF619084S, RPF619475S, RPF619476S, RPF619729S, RPF609798S, RPF609803S, RPF609809S, RPF610924S, RPF610929S, RPF610935S, RPF610938S, RPF610947S, RPF614776S, RPF614782S, RPF618353S, RPF618354S, RPF618355S, RPF618356S, RPF618357S, RPF618358S, RPF618361S, RPF618362S, RPF608224S, RPF608225S, RPF611060S, RPF614821S, RPF616957S, RPF617031S, RPF618423S, RPF618476S, RPF619798S, RPF620332S, RPF621332S, RPF622094S, RPF620132S, RPF621989S, RPF615594S, RPF615595S, RPF620714S, RPF623023S, RPF612794S, RPF612795S, RPF612796S, RPF612799S, RPF612800S, RPF612801S, RPF612802S, RPF612829S, RPF612831S, RPF612833S, RPF613375S, RPF613376S, RPF613377S, RPF613378S, RPF613422S, RPF613858S, RPF613859S, RPF613860S, RPF613861S, RPF613862S, RPF613864S, RPF613865S, RPF613866S, RPF613867S, RPF613868S, RPF613869S, RPF613870S, RPF613874S, RPF613876S, RPF613881S, RPF613885S, RPF613887S, RPF614969S, RPF615082S, RPF615086S, RPF615260S, RPF615261S, RPF615268S, RPF615269S, RPF615273S, RPF615274S, RPF615275S, RPF615661S, RPF615676S, RPF615705S, RPF615710S, RPF615720S, RPF615724S, RPF615732S, RPF616201S, RPF616631S, RPF616709S, RPF617985S, RPF617986S, RPF617991S, RPF617995S, RPF617996S, RPF618455S, RPF618456S, RPF618457S, RPF618458S, RPF618459S, RPF618460S, RPF618462S, RPF618961S, RPF619265S, RPF619266S, RPF619276S, RPF619277S, RPF619280S, RPF619282S, RPF619283S, RPF619285S, RPF619514S, RPF619515S, RPF619520S, RPF619522S, RPF619571S, RPF620679S, RPF620683S, RPF620685S, RPF620686S, RPF620980S, RPF621053S, RPF621063S, RPF621070S, RPF621075S, RPF621089S, RPF621092S, RPF621096S, RPF621100S, RPF621103S, RPF621113S, RPF621220S, RPF621455S, RPF621456S, RPF621458S, RPF621460S, RPF621463S, RPF621559S, RPF621566S, RPF621568S, RPF622058S, RPF622059S, RPF622060S, RPF622128S, RPF622130S, RPF622493S, RPF622498S, RPF622499S, RPF622503S, RPF622507S, RPF622822S, RPF622865S, RPF622960S, RPF622971S, RPF622972S, RPF622973S, RPF622548S, RPF622555S, RPF606088S, RPF607086S, RPF607088S, RPF607090S, RPF607908S, RPF607919S, RPF620057S, RPF622547S, RPF622553S, RPF622558S, RPF622559S, RPF622560S, RPF622567S, RPF607080S, RPF608817S, RPF609185S, RPF609193S, RPF607918S, RPF606157S, RPF607909S, RPF619237S, RPF620030S, RPF607912S, RPF620069S, RPF607082S, RPF607087S, RPF607902S, RPF619249S, RPF620029S, RPF622543S, RPF605750S, RPF605809S, RPF607054S, RPF604763S, RPF605081S, RPF607915S, RPF618417S, RPF619239S, RPF620045S, RPF622554S, RPF622561S, RPF622564S, RPF622566S, RPF619942S, RPF608516S, RPF608658S, RPF608689S, RPF622546S, RPF608485S, RPF622544S, RPF606906S, RPF608468S, RPF612847S, RPF617640S, RPF619241S, RPF619468S, RPF619587S, RPF620021S, RPF620035S, RPF612668S, RPF612676S, RPF612678S, RPF612683S, RPF621582S, RPF621585S, RPF621696S, RPF621715S, RPF621719S, RPF621733S, RPF609769S, RPF617785S, RPF620333S, RPF621310S, RPF622689S, RPF621169S, RPF622789S, RPF605766S, RPF606735S, RPF607060S, RPF607152S, RPF610673S, RPF611228S, RPF611374S, RPF613413S, RPF613656S, RPF617688S, RPF619815S, RPF618174S, RPF618597S, RPF618598S, RPF619863S, RPF620702S, RPF622105S, RPF618122S, RPF620451S, RPF621034S, RPF621104S, RPF621400S, RPF621975S, RPF623012S, RPF618507S, RPF619094S, RPF622222S, RPF621031S, RPF621178S, RPF622100S, RPF620486S, RPF622074S, RPF616097S, RPF617096S, RPF617843S, RPF618448S, RPF620478S, RPF621091S, RPF621267S, RPF622164S, RPF622888S, RPF610884S, RPF615401S, RPF618470S, RPF618497S, RPF619878S, RPF620015S, RPF620118S, RPF621009S, RPF622101S, RPF622511S, RPF622887S, RPF622900S, RPF606608S, RPF608132S, RPF605878S, RPF605370S, RPF604847S, RPF605449S, RPF605723S, RPF606045S, RPF608183S, RPF608443S, RPF608503S, RPF608657S, RPF609755S
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.