FDAClass IJune 28, 2023

Icd-vr Dvbb2d4 Evera XT Df4 Intl recall

ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators

Why was Icd-vr Dvbb2d4 Evera XT Df4 Intl recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN 00643169218024, Lot Serial Numbers: BWJ607141S, BWJ607132S, BWJ607040S, BWJ607055S, BWJ607056S, BWJ607025S; GTIN 00643169969575, Lot Serial Numbers: BWJ607007S, BWJ607008S, BWJ607010S, BWJ607011S, BWJ607012S, BWJ607015S, BWJ607020S, BWJ607022S, BWJ607024S, BWJ607029S, BWJ607034S, BWJ607035S, BWJ607037S, BWJ607077S, BWJ607347S, BWJ607043S, BWJ607091S, BWJ607094S, BWJ607095S, BWJ607101S, BWJ607342S, BWJ607343S, BWJ607344S, BWJ606951S, BWJ606991S, BWJ606994S, BWJ607005S, BWJ607060S, BWJ607090S, BWJ607096S, BWJ607097S, BWJ607098S, BWJ607120S, BWJ607121S, BWJ607127S, BWJ607145S, BWJ607146S, BWJ607147S, BWJ607149S, BWJ607156S, BWJ607158S, BWJ607159S, BWJ607160S, BWJ607162S, BWJ607092S, BWJ607093S, BWJ607003S, BWJ607288S, BWJ607280S, BWJ607282S, BWJ607286S, BWJ607287S, BWJ606996S, BWJ606998S, BWJ607016S, BWJ607019S, BWJ607057S, BWJ607061S, BWJ607062S, BWJ607063S, BWJ607074S, BWJ607078S, BWJ607082S, BWJ607084S, BWJ607085S, BWJ607104S, BWJ607105S, BWJ607106S, BWJ607123S, BWJ607124S, BWJ607131S, BWJ607163S, BWJ607168S, BWJ607174S, BWJ607178S, BWJ607179S, BWJ607182S, BWJ607069S, BWJ607079S, BWJ607107S, BWJ607108S, BWJ607114S, BWJ607115S, BWJ607126S, BWJ607151S, BWJ607161S, BWJ607181S, BWJ607273S, BWJ607064S, BWJ607109S, BWJ607117S, BWJ607152S, BWJ607175S, BWJ607272S, BWJ607153S, BWJ607166S, BWJ607170S, BWJ607274S, BWJ607276S, BWJ607278S, BWJ607291S, BWJ607176S, BWJ606995S, BWJ606997S, BWJ607046S, BWJ607051S, BWJ607052S, BWJ607054S, BWJ607065S, BWJ607067S, BWJ607068S, BWJ607070S, BWJ607075S, BWJ607076S, BWJ607083S, BWJ607086S, BWJ607088S, BWJ607089S, BWJ607099S, BWJ607002S, BWJ607087S, BWJ606993S, BWJ606992S, BWJ606950S, BWJ607042S, BWJ607073S, BWJ607277S, BWJ607242S, BWJ607243S, BWJ607244S, BWJ607245S, BWJ607246S, BWJ607247S, BWJ607248S, BWJ607249S, BWJ607250S, BWJ607251S, BWJ607275S, BWJ607283S, BWJ607284S, BWJ607285S, BWJ607290S, BWJ607006S, BWJ607013S, BWJ607039S, BWJ607071S, BWJ607072S, BWJ607118S, BWJ607281S; GTIN 00643169980259, Lot Serial Numbers: BWJ607465S, BWJ607467S, BWJ607468S, BWJ607580S, BWJ607395S, BWJ607338S, BWJ607339S, BWJ607340S, BWJ607341S, BWJ607352S, BWJ607353S, BWJ607354S, BWJ607355S, BWJ607356S, BWJ607357S, BWJ607358S, BWJ607359S, BWJ607360S, BWJ607361S, BWJ607438S, BWJ607377S, BWJ607378S, BWJ607381S, BWJ607382S, BWJ607383S, BWJ607385S, BWJ607386S, BWJ607387S, BWJ607389S, BWJ607390S, BWJ607413S, BWJ607416S, BWJ607418S, BWJ607420S, BWJ607511S, BWJ607517S, BWJ607521S, BWJ607522S, BWJ607743S, BWJ607769S, BWJ607772S, BWJ607774S, BWJ607776S, BWJ607786S, BWJ607376S, BWJ607375S, BWJ607380S, BWJ607516S, BWJ607541S, BWJ607562S, BWJ607612S, BWJ607641S, BWJ607749S, BWJ607755S, BWJ607770S, BWJ607781S, BWJ607722S, BWJ607747S, BWJ607497S, BWJ607498S, BWJ607568S, BWJ607607S, BWJ607495S, BWJ607537S, BWJ607566S, BWJ607482S, BWJ607514S, BWJ607518S, BWJ607567S, BWJ607555S, BWJ607460S, BWJ607333S, BWJ607398S, BWJ607399S, BWJ607500S, BWJ607483S, BWJ607484S, BWJ607485S, BWJ607486S, BWJ607487S, BWJ607492S, BWJ607493S, BWJ607494S, BWJ607524S, BWJ607525S, BWJ607547S, BWJ607563S, BWJ607564S, BWJ607573S, BWJ607588S, BWJ607589S, BWJ607590S, BWJ607591S, BWJ607592S, BWJ607593S, BWJ607594S, BWJ607595S, BWJ607596S, BWJ607597S, BWJ607598S, BWJ607600S, BWJ607603S, BWJ607604S, BWJ607605S, BWJ607606S, BWJ607527S, BWJ607528S, BWJ607529S, BWJ607530S, BWJ607545S, BWJ607556S, BWJ607572S, BWJ607608S, BWJ607311S, BWJ607520S, BWJ607457S, BWJ607557S, BWJ607560S, BWJ607301S, BWJ607579S, BWJ607292S, BWJ607704S, BWJ607705S, BWJ607706S, BWJ607707S, BWJ607709S, BWJ607710S, BWJ607711S, BWJ607305S, BWJ607697S, BWJ607388S, BWJ607195S, BWJ607558S, BWJ607337S, BWJ607194S, BWJ607685S, BWJ607686S, BWJ607293S, BWJ607198S, BWJ607202S, BWJ607212S, BWJ607213S, BWJ607214S, BWJ607215S, BWJ607216S, BWJ607217S, BWJ607218S, BWJ607219S, BWJ607220S, BWJ607221S, BWJ607222S, BWJ607223S, BWJ607225S, BWJ607226S, BWJ607227S, BWJ607295S, BWJ607296S, BWJ607297S, BWJ607298S, BWJ607299S, BWJ607300S, BWJ607319S, BWJ607320S, BWJ607321S, BWJ607322S, BWJ607323S, BWJ607324S, BWJ607325S, BWJ607326S, BWJ607327S, BWJ607328S, BWJ607329S, BWJ607330S, BWJ607331S, BWJ607332S, BWJ607302S, BWJ607303S, BWJ607304S, BWJ607306S, BWJ607307S, BWJ607309S, BWJ607310S, BWJ607312S, BWJ607313S, BWJ607314S, BWJ607316S, BWJ607317S, BWJ607335S, BWJ607336S, BWJ607110S, BWJ607111S, BWJ607183S, BWJ607184S, BWJ607185S, BWJ607186S, BWJ607187S, BWJ607188S, BWJ607189S, BWJ607190S, BWJ607197S, BWJ607204S, BWJ607209S, BWJ607540S, BWJ607546S, BWJ607523S, BWJ607654S, BWJ607455S, BWJ607458S, BWJ607571S, BWJ607601S, BWJ607496S, BWJ607552S, BWJ607582S, BWJ607583S, BWJ607648S, BWJ607651S, BWJ607575S, BWJ607499S, BWJ607550S, BWJ607394S, BWJ607393S, BWJ607396S, BWJ607397S, BWJ607429S, BWJ607430S, BWJ607431S, BWJ607462S, BWJ607609S, BWJ607526S, BWJ607553S, BWJ607610S, BWJ607551S, BWJ607578S, BWJ607577S, BWJ607519S, BWJ607535S, BWJ607574S, BWJ607400S, BWJ607401S, BWJ607402S, BWJ607403S, BWJ607404S, BWJ607405S, BWJ607406S, BWJ607407S, BWJ607408S, BWJ607409S, BWJ607410S, BWJ607411S, BWJ607412S, BWJ607414S, BWJ607415S, BWJ607417S, BWJ607423S, BWJ607424S, BWJ607426S, BWJ607432S, BWJ607433S, BWJ607434S, BWJ607435S, BWJ607436S, BWJ607437S, BWJ607439S, BWJ607440S, BWJ607441S, BWJ607442S, BWJ607443S, BWJ607444S, BWJ607445S, BWJ607446S, BWJ607447S, BWJ607448S, BWJ607449S, BWJ607450S, BWJ607451S, BWJ607452S, BWJ607453S, BWJ607454S, BWJ607554S, BWJ607544S, BWJ607650S, BWJ607559S, BWJ607748S, BWJ607576S, BWJ607561S, BWJ607570S, BWJ607586S; GTIN 00763000612122, Lot Serial numbers: BWJ607792S, BWJ607798S, BWJ607795S, BWJ607796S, BWJ607797S

Product
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity
447 units
Distribution
US Nationwide - Worldwide Distribution
Recall date
June 28, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls