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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DualChamber External Temporary Pulse Generators Model 5388

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 Class 2 Device Recall Medtronic DualChamber External Temporary Pulse Generators Model 5388 see related information
Date Posted November 22, 2010
Recall Status1 Terminated on May 29, 2012
Recall Number Z-0430-2011
Recall Event ID 57098
PMA Number P820003S072 
Product Classification Implantable pulse generator, pacemaker (non-crt) - Product Code LWP
Product Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.
Code Information Serial numbers: PEG026278, PFG001362P, PFG001406P, PFG001755P, PFG001906P, PFG001918P, PFG002648P, PFG002911P, PFG002929P, PFG003371P, PFG003923P, PFG003932P, PFG003933P, PFG004462P, PFG005391P, PFG007169P, PFG008759P, PFG015326P, PFG01534P, PFG015449P, PFG017606P, PFG018062P, PFG018161P, PFG018176P, PFG018429P, PFG018475P, PFG020770P, PFG021284P, PFG021309P, PFG022541P, PFG022740P, PFG022864P, PFG022902P, PFG023043P, PFG023107P, PFG023108P, PFG023473P, PFG023518P, PFG023608P, PFG023933P, PFG023987P, PFG024002P, PFG025347P, PFG025736P, PFG025746P, PFG026378P, PFG028007P, PFG028350P, PFG028755P, PFG028986P, PFG029169P, PFG029173P, PFG029174P, PFG029175P, PFG029176P, PFG029177P, PFG029237P, PFG029603P, PFG029604P, PFG029808P, PFG029967P, PFG030425P, PFG030707P, PFG031194P, PFG031195P, PFG031197P, PFG031386P, PFG031538P, PFG031539P, PFG031540P, PFG031543P, PFG031789P, PFG031838P, PFG032089P, PFG032121P, PFG033136P, PFG033229P, PFG033266P, PFG033323P, PFG033537P, PFG033703P, PFG033791P, PFG034239P, PFG034732P thru PFG034769P, PFG034770P, PFG034771P, PFG034772P, PFG050100P thru PFG050137P, PFG050139P, PFG050140P, PFG050141P, PFG050142P, PFG050144P, PFG050146P thru PFG050162P, PFG050165P, PFG050166P, PFG050167P, PFG050168P, PFG050169P, PFG050170P, PFG050171P, PFG050172P, PFG050173P, PFG050175P, PFG050176P, PFG050177P, PFG050178P, PFG050179P, PFG050180P, PFG050182P, PFG050183P, PFG050184P, PFG050185P, PFG050186P, PFG050187P, PFG050188P, PFG050189P, PFG050191P thru PFG050243P, PFG050246P thru PFG050263P, PFG050266P, PFG050267P, PFG050269P, PFG050270P, PFG050271P, PFG050273P, PFG050274P, PFG050275P, PFG050277P, PFG050278P, PFG050279P, PFG050280P, PFG050281P, PFG050282P, PFG050283P, PFG050284P, PFG050285P, PFG050287P, PFG050288P, PFG050289P, PFG050290P, PFG050291P, PFG050292P, PFG050293P, PFG050294P, PFG050295P, PFG050296P, PFG050297P, PFG050298P, PFG050299P, PFG050300P, PFG050302P thru PFG050323P, PFG050325P thru PFG050367P, PFG050369P, PFG050370P, PFG050371P, PFG050372P, PFG050373P, PFG050374P, PFG050375P, PFG050376P, PFG050378P thru PFG050391P, PFG050393P, PFG050395P, PFG050397P, PFG050398P, PFG050399P, PFG050401P thru PFG050466P, PFG050468P thru PFG050524P, PFG050526P, PFG050528P, PFG050529P, PFG050530P, PFG050532P, PFG050533P, PFG050535P, PFG050538P thru PFG050555P, PFG050557P, PFG050558P, PFG050560P thru PFG050577P, PFG050579P, PFG050580P, PFG050582P, PFG050586P, PFG050587P, PFG050588P, PFG050589P, PFG050590P, PFG050592P, PFG050593P, PFG050594P, PFG050598P, PFG050599P, PFG050600P, PFG050601P, PFG050602P, PFG050603P, PFG050604P, PFG050605P, PFG050606P, PFG050607P, PFG050608P, PFG050609P, PFG050610P, PFG050611P, PFG050613P, PFG050614P, PFG050615P, PFG050617P thru PFG050653P, PFG050655P thru PFG050682P, PFG050684P, PFG050685P, PFG050686P, PFG050687P, PFG050688P, PFG050690P, PFG050693P, PFG050695P thru PFG050710P, PFG050712P, PFG050716P, PFG050717P, PFG050720P, PFG050721P, PFG050724P thru PFG050741P, PFG050746P, PFG050747P, PFG050748P, PFG050749P, PFG050750P, PFG050751P, PFG050753P thru PFG050763P, PFG050765P, PFG050767P, PFG050769P, PFG050770P, PFG050772P, PFG050775P, PFG050776P, PFG050777P, PFG050780P thru PFG050797P, PFG050800P thru PFG050887P, PFG050890P, PFG050891P, PFG050892P, PFG050893P, PFG050895P thru PFG050917P, PFG050919P thru PFG050931P, PFG050933P, PFG050935P, PFG050936P, PFG050937P, PFG050938P, PFG050940P, PFG050941P, PFG050942P, PFG050943P, PFG050945P thru PFG050963P, PFG050965P thru PFG050997P, PFG050999P, PFG051000P, PFG051001P, PFG051002P, PFG051003P, PFG051004P, PFG051005P, PFG051006P, PFG051007P, PFG051008P, PFG051009P, PFG051010P, PFG051012P thru PFG051043P, PFG051045P, PFG051046P, PFG051050P, PFG051051P, PFG051052P, PFG051053P, PFG051054P, PFG051055P, PFG051056P, PFG051057P, PFG051058P, PFG051060P thru PFG051083P, PFG051085P thru PFG051130P, PFG051133P thru PFG051144P, PFG051146P, PFG051148P thru PFG051178P, PFG051181P thru PFG051235P, PFG051237P thru PFG051288P, PFG051290P thru PFG051374P, PFG051376P thru PFG0
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
763-526-4000
For Additional Information Contact Instruments Technical Service
800-638-1991
Manufacturer Reason
for Recall
A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down at a later time while in use.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Medtronic issued an Important Medical Device Correction letters, dated October 2010 and November 2010 to hospital's biomedical engineering department. The letter described the issue, how it presents, and stated that Medtronic will contact the hospitals to return affected product for servicing. The second letter reiterated that Medtronic would notify customers when FDA approves their design upgrade for returning devices for service. In the interim, hospitals should continue to use normally functioning devices. Cusotmers may contact Medtronic Instruments Technical Service at 800-638-1991 concerning this action.
Quantity in Commerce 5,595 ( 2,696 US, 2,899 OUS) EXPANDED: 944 (852 US, 92 OUS)
Distribution Worldwide Distribution: throughout USA and territories of Guam and Puerto Rico and to the countries of: Algeria, Argentina, Australia, Austria, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Guiana, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen NO ADDITIONAL COUNTRIES ARE AFFECTED BY THE EXPANSION.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWP and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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