Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

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PEP002797P, PEP002798P, PEP002799P, PEP002800P, PEP002801P, PEP002802P, PEP002803P, PEP002804P, PEP002805P, PEP002806P, PEP002807P, PEP002808P, PEP002809P, PEP002810P, PEP002811P, PEP002812P, PEP002813P, PEP002814P, PEP002815P, PEP002816P, PEP002817P, PEP002818P, PEP002819P, PEP002820P, PEP002821P, PEP002822P, PEP002823P, PEP002824P, PEP002825P, PEP002826P, PEP002827P, PEP002828P, PEP002829P, PEP002830P, PEP002831P, PEP002832P, PEP002833P, PEP002834P, PEP002835P, PEP002836P, PEP002837P, PEP002838P, PEP002839P, PEP002840P, PEP002841P, PEP002842P, PEP002843P, PEP002844P, PEP002845P, PEP002846P, PEP002847P, PEP002848P, PEP002849P, PEP002850P, PEP002851P, PEP002852P, PEP002853P, PEP002854P, PEP002855P, PEP002856P, PEP002857P, PEP002858P, PEP002859P, PEP002860P, PEP002861P, PEP002862P, PEP002863P, PEP002864P, PEP002865P, PEP002866P, PEP002867P, PEP002868P, PEP002869P, PEP002870P, PEP002871P, PEP002872P, PEP002873P, PEP002874P, PEP002875P, PEP002876P, PEP002877P, PEP002878P, PEP002879P, PEP002880P, PEP002881P, PEP002882P, PEP002883P, PEP002884P, PEP002885P, PEP002886P, PEP002887P, PEP002888P, PEP002889P, PEP002890P, PEP002891P, PEP002892P, PEP002893P, PEP002894P, PEP002895P, PEP002896P, PEP002897P, PEP002898P, PEP002899P, PEP002900P, PEP002901P, PEP002902P, PEP002903P, PEP002904P, PEP002905P, PEP002906P, PEP002907P, PEP002908P, PEP002909P, PEP002910P, PEP002911P, PEP002912P, PEP002913P, PEP002914P, PEP002915P, PEP002916P, PEP002917P, PEP002918P, PEP002919P, PEP002920P, PEP002921P, PEP002922P, PEP002923P, PEP002924P, PEP002925P, PEP002926P, PEP002927P, PEP002928P, PEP002929P, PEP002930P, PEP002931P, PEP002932P, PEP002933P, PEP002934P, PEP002935P, PEP002936P, PEP002937P, PEP002938P, PEP002939P, PEP002940P, PEP002941P, PEP002942P, PEP002943P, PEP002944P, PEP002945P, PEP002946P, PEP002947P, PEP002948P, PEP002949P, PEP002950P, PEP002951P, PEP002952P, PEP002953P, PEP002954P, PEP002955P, PEP002956P, PEP002957P, PEP002958P, PEP002959P, PEP002960P, PEP002961P, PEP002962P, PEP002963P, PEP002964P, PEP002965P, PEP002966P, PEP002967P, PEP002968P, PEP002969P, PEP002970P, PEP002971P, PEP002972P, PEP002973P, PEP002974P, PEP002975P, PEP002976P, PEP002977P, PEP002978P, PEP002979P, PEP002980P, PEP002981P, PEP002982P, PEP002983P, PEP002984P, PEP002985P, PEP002986P, PEP002987P, PEP002988P, PEP002989P, PEP002990P, PEP002991P, PEP002992P, PEP002993P, PEP002994P, PEP002995P, PEP002996P, PEP002997P, PEP002998P, PEP002999P, PEP003000P, PEP003001P, PEP003002P, PEP003003P, PEP003004P, PEP003005P, PEP003006P, PEP003007P, PEP003008P, PEP003009P, PEP003010P, PEP003011P, PEP003012P, PEP003013P, PEP003014P, PEP003015P, PEP003016P, PEP003017P, PEP003018P, PEP003019P, PEP003020P, PEP003021P, PEP003022P, PEP003023P, PEP
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Inc. Cardiac Rhythm Disease Management
Reason for Recall:
Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

Product Codes/Lot Numbers:

serial numbers: PEP001001K, PEP001001P, PEP001002K, PEP001002P, PEP001003K, PEP001003P, PEP001004K, PEP001004P, PEP001005K, PEP001005P, PEP001006K, PEP001006P, PEP001007K, PEP001007P, PEP001008K, PEP001008P, PEP001009K, PEP001009P, PEP001010K, PEP001010P, PEP001011K, PEP001011P, PEP001012K, PEP001012P, PEP001013K, PEP001013P, PEP001014K, PEP001014P, PEP001015K, PEP001015P, PEP001016K, PEP001016P, PEP001017K, PEP001017P, PEP001018K, PEP001018P, PEP001019K, PEP001019P, PEP001020K, PEP001020P, PEP001021K, PEP001021P, PEP001022K, PEP001022P, PEP001023K, PEP001023P, PEP001024K, PEP001024P, PEP001025K, PEP001025P, PEP001026K, PEP001026P, PEP001027K, PEP001027P, PEP001028K, PEP001028P, PEP001029K, PEP001029P, PEP001030K, PEP001030P, PEP001031K, PEP001031P, PEP001032K, PEP001032P, PEP001033K, PEP001033P, PEP001034K, PEP001034P, PEP001035K, PEP001035P, PEP001036K, PEP001036P, PEP001037K, PEP001037P, PEP001038K, PEP001038P, PEP001039K, PEP001039P, PEP001040K, PEP001040P, PEP001041K, PEP001041P, PEP001042K, PEP001042P, PEP001043K, PEP001043P, PEP001044K, PEP001044P, PEP001045K, PEP001045P, PEP001046K, PEP001046P, PEP001047K, PEP001047P, PEP001048K, PEP001048P, PEP001049K, PEP001049P, PEP001050K, PEP001050P, PEP001051K, PEP001051P, PEP001052K, PEP001052P, PEP001053K, PEP001053P, PEP001054K, PEP001054P, PEP001055K, PEP001055P, PEP001056K, PEP001056P, PEP001057K, PEP001057P, PEP001058K, PEP001058P, PEP001059K, PEP001059P, PEP001060K, PEP001060P, PEP001061K, PEP001061P, PEP001062K, PEP001062P, PEP001063K, PEP001063P, PEP001064K, PEP001064P, PEP001065K, PEP001065P, PEP001066K, PEP001066P, PEP001067K, PEP001067P, PEP001068K, PEP001069K, PEP001069P, PEP001070K, PEP001070P, PEP001071K, PEP001071P, PEP001072K, PEP001072P, PEP001073K, PEP001073P, PEP001074K, PEP001074P, PEP001075K, PEP001075P, PEP001076K, PEP001076P, PEP001077K, PEP001077P, PEP001078K, PEP001078P, PEP001079K, PEP001079P, PEP001080K, PEP001080P, PEP001081K, PEP001081P, PEP001082K, PEP001082P, PEP001083K, PEP001083P, 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PEP001209K, PEP001209P, PEP001210K, PEP001210P, PEP001211K, PEP001211P, PEP001212K, PEP001212P, PEP001213K, PEP001213P, PEP001214K, PEP001214P, PEP001215K, PEP001215P, PEP001216K, PEP001216P, PEP001217K, PEP001217P, PEP001218K, PEP001218P, PEP001219K, PEP001219P, PEP001220K, PEP001220P, PEP001221K, PEP001221P, PEP001222K, PEP001222P, PEP001223K, PEP001223P, PEP001224K, PEP001224P, PEP001225K, PEP001225P, PEP001226K, PEP001226P, PEP001227K, PEP001227P, PEP001228K, PEP001228P, PEP001229K, PEP001229P, PEP001230K, PEP001230P, PEP001231K, PEP001231P, PEP001232K, PEP001232P, PEP001233K, PEP001233P, PEP001234K, PEP001235K, PEP001236K, PEP001236P, PEP001237K, PEP001237P, PEP001238K, PEP001238P, PEP001239K, PEP001239P, PEP001240K, PEP001240P, PEP001241K, PEP001241P, PEP001242K, PEP001242P, PEP001243K, PEP001243P, PEP001244P, PEP001245K, PEP001245P, PEP001246K, PEP001246P, PEP001247K, PEP001247P, PEP001248K, PEP001248P, PEP001249K, PEP001249P, PEP001250K, PEP001250P, PEP001251K, PEP001251P, 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PEP001293P, PEP001294K, PEP001294P, PEP001295K, PEP001295P, PEP001296K, PEP001296P, PEP001297K, PEP001297P, PEP001298K, PEP001299K, PEP001300K, PEP001301K, PEP001301P, PEP001302K, PEP001302P, PEP001303K, PEP001303P, PEP001304K, PEP001304P, PEP001305K, PEP001305P, PEP001306K, PEP001306P, PEP001307K, PEP001307P, PEP001308K, PEP001308P, PEP001309K, PEP001309P, PEP001310K, PEP001310P, PEP001311K, PEP001311P, PEP001312K, PEP001312P, PEP001313K, PEP001313P, PEP001314K, PEP001314P, PEP001315K, PEP001315P, PEP001316K, PEP001316P, PEP001317K, PEP001317P, PEP001318K, PEP001318P, PEP001319K, PEP001319P, PEP001320K, PEP001320P, PEP001321K, PEP001321P, PEP001322K, PEP001322P, PEP001323K, PEP001323P, PEP001324K, PEP001324P, PEP001325K, PEP001325P, PEP001326K, PEP001326P, PEP001327K, PEP001327P, PEP001328K, PEP001328P, PEP001329K, PEP001329P, PEP001330K, PEP001330P, PEP001331K, PEP001332K, PEP001333K, PEP001333P, PEP001334K, PEP001334P, PEP001335K, PEP001335P, PEP001336K, PEP001336P, PEP001337K, 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PEP002549P, PEP002550P, PEP002551P, PEP002552P, PEP002553P, PEP002554P, PEP002555P, PEP002556P, PEP002557P, PEP002558P, PEP002559P, PEP002560P, PEP002561P, PEP002562P, PEP002563P, PEP002564P, PEP002565P, PEP002566P, PEP002567P, PEP002568P, PEP002569P, PEP002570P, PEP002571P, PEP002572P, PEP002573P, PEP002574P, PEP002575P, PEP002576P, PEP002577P, PEP002578P, PEP002579P, PEP002580P, PEP002581P, PEP002582P, PEP002583P, PEP002584P, PEP002585P, PEP002586P, PEP002587P, PEP002588P, PEP002589P, PEP002590P, PEP002591P, PEP002592P, PEP002593P, PEP002594P, PEP002595P, PEP002596P, PEP002597P, PEP002598P, PEP002599P, PEP002600P, PEP002601P, PEP002602P, PEP002603P, PEP002604P, PEP002605P, PEP002606P, PEP002607P, PEP002608P, PEP002609P, PEP002610P, PEP002611P, PEP002612P, PEP002613P, PEP002614P, PEP002615P, PEP002616P, PEP002617P, PEP002618P, PEP002619P, PEP002620P, PEP002621P, PEP002622P, PEP002623P, PEP002624P, PEP002625P, PEP002626P, PEP002627P, PEP002628P, PEP002629P, PEP002630P, PEP002631P, PEP002632P, PEP002633P, PEP002634P, PEP002635P, PEP002636P, PEP002637P, PEP002638P, PEP002639P, PEP002640P, PEP002641P, PEP002642P, PEP002643P, PEP002644P, PEP002645P, PEP002646P, PEP002647P, PEP002648P, PEP002649P, PEP002650P, PEP002651P, PEP002652P, PEP002653P, PEP002654P, PEP002655P, PEP002656P, PEP002657P, PEP002658P, PEP002659P, PEP002660P, PEP002661P, PEP002662P, PEP002663P, PEP002664P, PEP002665P, PEP002666P, PEP002667P, PEP002668P, PEP002669P, PEP002670P, PEP002671P, PEP002672P, PEP002673P, PEP002674P, PEP002675P, PEP002676P, PEP002677P, PEP002678P, PEP002679P, PEP002680P, PEP002681P, PEP002682P, PEP002683P, PEP002684P, PEP002685P, PEP002686P, PEP002687P, PEP002688P, PEP002689P, PEP002690P, PEP002691P, PEP002692P, PEP002693P, PEP002694P, PEP002695P, PEP002696P, PEP002697P, PEP002698P, PEP002699P, PEP002700P, PEP002701P, PEP002702P, PEP002703P, PEP002704P, PEP002705P, PEP002706P, PEP002707P, PEP002708P, PEP002709P, PEP002710P, PEP002711P, PEP002712P, PEP002713P, PEP002714P, PEP002715P, PEP002716P, PEP002717P, PEP002718P, PEP002719P, PEP002720P, PEP002721P, PEP002722P, PEP002723P, PEP002724P, PEP002725P, PEP002726P, PEP002727P, PEP002728P, PEP002729P, PEP002730P, PEP002731P, PEP002732P, PEP002733P, PEP002734P, PEP002735P, PEP002736P, PEP002737P, PEP002738P, PEP002739P, PEP002740P, PEP002741P, PEP002742P, PEP002743P, PEP002744P, PEP002745P, PEP002746P, PEP002747P, PEP002748P, PEP002749P, PEP002750P, PEP002751P, PEP002752P, PEP002753P, PEP002754P, PEP002755P, PEP002756P, PEP002757P, PEP002758P, PEP002759P, PEP002760P, PEP002761P, PEP002762P, PEP002763P, PEP002764P, PEP002765P, PEP002766P, PEP002767P, PEP002768P, PEP002769P, PEP002770P, PEP002771P, PEP002772P, PEP002773P, PEP002774P, PEP002775P, PEP002776P, PEP002777P, PEP002778P, PEP002779P, PEP002780P, PEP002781P, PEP002782P, PEP002783P, PEP002784P, PEP002785P, PEP002786P, PEP002787P, PEP002788P, PEP002789P, PEP002790P, PEP002791P, PEP002792P, PEP002793P, PEP002794P, PEP002795P, PEP002796P, PEP002797P, PEP002798P, PEP002799P, PEP002800P, PEP002801P, PEP002802P, PEP002803P, PEP002804P, PEP002805P, PEP002806P, PEP002807P, PEP002808P, PEP002809P, PEP002810P, PEP002811P, PEP002812P, PEP002813P, PEP002814P, PEP002815P, PEP002816P, PEP002817P, PEP002818P, PEP002819P, PEP002820P, PEP002821P, PEP002822P, PEP002823P, PEP002824P, PEP002825P, PEP002826P, PEP002827P, PEP002828P, PEP002829P, PEP002830P, PEP002831P, PEP002832P, PEP002833P, PEP002834P, PEP002835P, PEP002836P, PEP002837P, PEP002838P, PEP002839P, PEP002840P, PEP002841P, PEP002842P, PEP002843P, PEP002844P, PEP002845P, PEP002846P, PEP002847P, PEP002848P, PEP002849P, PEP002850P, PEP002851P, PEP002852P, PEP002853P, PEP002854P, PEP002855P, PEP002856P, PEP002857P, PEP002858P, PEP002859P, PEP002860P, PEP002861P, PEP002862P, PEP002863P, PEP002864P, PEP002865P, PEP002866P, PEP002867P, PEP002868P, PEP002869P, PEP002870P, PEP002871P, PEP002872P, PEP002873P, PEP002874P, PEP002875P, PEP002876P, PEP002877P, PEP002878P, PEP002879P, PEP002880P, PEP002881P, PEP002882P, PEP002883P, PEP002884P, PEP002885P, PEP002886P, PEP002887P, PEP002888P, PEP002889P, PEP002890P, PEP002891P, PEP002892P, PEP002893P, PEP002894P, PEP002895P, PEP002896P, PEP002897P, PEP002898P, PEP002899P, PEP002900P, PEP002901P, PEP002902P, PEP002903P, PEP002904P, PEP002905P, PEP002906P, PEP002907P, PEP002908P, PEP002909P, PEP002910P, PEP002911P, PEP002912P, PEP002913P, PEP002914P, PEP002915P, PEP002916P, PEP002917P, PEP002918P, PEP002919P, PEP002920P, PEP002921P, PEP002922P, PEP002923P, PEP002924P, PEP002925P, PEP002926P, PEP002927P, PEP002928P, PEP002929P, PEP002930P, PEP002931P, PEP002932P, PEP002933P, PEP002934P, PEP002935P, PEP002936P, PEP002937P, PEP002938P, PEP002939P, PEP002940P, PEP002941P, PEP002942P, PEP002943P, PEP002944P, PEP002945P, PEP002946P, PEP002947P, PEP002948P, PEP002949P, PEP002950P, PEP002951P, PEP002952P, PEP002953P, PEP002954P, PEP002955P, PEP002956P, PEP002957P, PEP002958P, PEP002959P, PEP002960P, PEP002961P, PEP002962P, PEP002963P, PEP002964P, PEP002965P, PEP002966P, PEP002967P, PEP002968P, PEP002969P, PEP002970P, PEP002971P, PEP002972P, PEP002973P, PEP002974P, PEP002975P, PEP002976P, PEP002977P, PEP002978P, PEP002979P, PEP002980P, PEP002981P, PEP002982P, PEP002983P, PEP002984P, PEP002985P, PEP002986P, PEP002987P, PEP002988P, PEP002989P, PEP002990P, PEP002991P, PEP002992P, PEP002993P, PEP002994P, PEP002995P, PEP002996P, PEP002997P, PEP002998P, PEP002999P, PEP003000P, PEP003001P, PEP003002P, PEP003003P, PEP003004P, PEP003005P, PEP003006P, PEP003007P, PEP003008P, PEP003009P, PEP003010P, PEP003011P, PEP003012P, PEP003013P, PEP003014P, PEP003015P, PEP003016P, PEP003017P, PEP003018P, PEP003019P, PEP003020P, PEP003021P, PEP003022P, PEP003023P, PEP

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1661-2014

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