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).

Recall details

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management

Distributor

Worldwide Distribution -- USA, including the territories of Guam and Puerto Rico; and, the countries of Albania, Algeria, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Burkina Faso, Chile, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.

Lot

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, PEP001084K, PEP001084P, PEP001085K, PEP001085P, PEP001086K, PEP001086P, PEP001087K, PEP001087P, PEP001088K, PEP001088P, PEP001089K, PEP001089P, PEP001090K, PEP001090P, PEP001091K, PEP001091P, PEP001092K, PEP001092P, PEP001093K, PEP001093P, PEP001094K, PEP001094P, PEP001095K, PEP001095P, PEP001096K, PEP001096P, PEP001097K, PEP001097P, PEP001098K, PEP001098P, PEP001099K, PEP001099P, PEP001100K, PEP001100P, PEP001101K, PEP001101P, PEP001102K, PEP001102P, PEP001103K, PEP001103P, PEP001104K, PEP001104P, PEP001105K, PEP001105P, PEP001106K, PEP001106P, PEP001107K, PEP001107P, PEP001108K, PEP001108P, PEP001109K, PEP001109P, PEP001110K, PEP001110P, PEP001111K, PEP001111P, PEP001112K, PEP001112P, PEP001113K, PEP001113P, PEP001114K, PEP001115K, PEP001115P, PEP001116K, PEP001116P, PEP001117K, PEP001117P, PEP001118K, PEP001118P, PEP001119K, PEP001119P, PEP001120K, PEP001120P, PEP001121K, PEP001121P, PEP001122K, PEP001122P, PEP001123K, PEP001123P, PEP001124K, PEP001124P, PEP001125K, PEP001125P, PEP001126K, PEP001126P, PEP001127K, PEP001127P, PEP001128K, PEP001128P, PEP001129K, PEP001129P, PEP001130K, PEP001130P, PEP001131K, PEP001131P, PEP001132K, PEP001132P, PEP001133K, PEP001133P, PEP001134K, PEP001134P, PEP001135K, PEP001135P, PEP001136K, PEP001136P, PEP001137K, PEP001137P, PEP001138K, PEP001138P, PEP001139K, PEP001139P, PEP001140K, PEP001140P, PEP001141K, PEP001141P, PEP001142K, PEP001142P, PEP001143K, PEP001143P, PEP001144K, PEP001144P, PEP001145K, PEP001145P, PEP001146K, PEP001146P, PEP001147K, PEP001147P, PEP001148K, PEP001148P, PEP001149K, PEP001149P, PEP001150K, PEP001150P, PEP001151K, PEP001151P, PEP001152K, PEP001152P, PEP001153K, PEP001153P, PEP001154K, PEP001154P, PEP001155K, PEP001155P, PEP001156K, PEP001156P, PEP001157K, PEP001157P, PEP001158K, PEP001158P, PEP001159K, PEP001159P, PEP001160K, PEP001160P, PEP001161K, PEP001161P, PEP001162K, PEP001162P, PEP001163K, PEP001163P, PEP001164K, PEP001164P, PEP001165K, PEP001165P, PEP001166K, PEP001166P, PEP001167K, PEP001167P,

Risk classification

Class II

Area (FDA)

device

Country

United States