FDAFDA · Food and drugs·Recall number Z-1524-2020
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Published March 25, 2020 · Recall initiated: January 30, 2020
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
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- Worldwide distribution. US Nationwide including Puerto Rico, Argentina, Brazil, Colombia, Trinidad and Tobago, Venezuela, Dominican Republic, Bahamas, Peru, Bermuda, Barbados, Ecuador, Cayman Islands, Curacao, Guatemala, Honduras, Panama, El Salvador, Costa Rica, Bolivia, Chile, Uruguay, Paraguay, Mexico, Jamaica, Japan, Belgium, Greece, Germany, Switzerland, United Kingdom, Spain, Italy, Luxembourg, Poland, Austria, Suriname, Netherlands, Aruba, Hungary, Liechtenstein, Sweden, Czech Republic, Ireland, France, French Polynesia, New Caledonia, Guadeloupe, Reunion, Mauritius, Kenya, South Africa, Uganda, Namibia, Finland, Norway, Portugal, Iceland, Denmark, Faroe Islands, Greenland, Macedonia, Iraq, Pakistan, Sudan, Jordan, Morocco, Belarus, Lebanon, Sri Lanka, Kazakhstan, Bulgaria, Egypt, Turkey, Libya, Serbia, Tunisia, Cyprus, Oman, Slovenia, Algeria, Malta, Croatia, Saudi Arabia, Syria, Kuwait, Latvia, Ukraine, Andorra, Burkina Faso, Nepal, Mayotte, French Guiana, Martinique, Bosnia And Herzegovina, Qatar, United Arab Emirates, Georgia, Yemen, Slovakia, Iran, Canada, Lithuania, United States, Cote D'Ivoire, Nicaragua, Zimbabwe, Azerbaijan, Albania, Ghana, India, Israel, Guam, American Samoa, Korea, Armenia, Mozambique, Nigeria, Bangladesh, Australia, Taiwan, Cambodia, Hong Kong, Malaysia, Viet Nam, Singapore, New Zealand, Indonesia, Philippines, Angola, Rwanda, Northern Mariana Islands, Senegal, Cameroon, Botswana,Russian Federation, Montenegro, China, Turkmenistan, St. Maarten, Tanzania, Kyrgyzstan, Netherlands Antilles, Cuba, Romania, Mongolia, Kosovo, Tajikistan, Benin, Ethiopia, Moldova, Afghanistan, Democratic Republic of Congo, and Thailand
- Lot
- Product Number 2090; All Serial Numbers; Known Model Numbers: a. Model Number 2090, GTIN (Lot Numbers): 00721902546341 (PKK002840R), 00721902246234 (PKK012608R), 00721902246234 (PKK013358R), 00721902569517 (PKK017436R), 00613994580955 (PKK204009R), 00643169537828 (PKK001072R), 00613994175397 (PKK001076R), 00613994175397 (PKK001135R), 00613994175397 (PKK001172R), 00613994175120 (PKK001321R), 00613994175106 (PKK001322R), 00721902246234 (PKK001324R), 00721902246227 (PKK001327R), 00613994175212 (PKK001328R), 00613994175106 (PKK001331R), 00643169537828 (PKK001332R), 00721902246234 (PKK001335R), 00613994175144 (PKK001348R), 00721902246227 (PKK001352R), 00613994175076 (PKK001358R), 00613994581075 (PKK001359R), 00721902246234 (PKK001361R), 00643169537828 (PKK001362R), 00613994175397 (PKK001364R), 00613994581204 (PKK001367R), 00613994175267 (PKK001373R), 00613994175397 (PKK001376R), 00613994175120 (PKK001382R), 00613994175397 (PKK001386R), 00613994175083 (PKK001387R), 00643169537828 (PKK001390R), 00613994175397 (PKK001395R), 00613994581235 (PKK001398R), 00613994175106 (PKK001400R), 00721902246234 (PKK001401R), 00613994175212 (PKK001403R), 00613994175106 (PKK001407R), 00613994136534 (PKK001409R), 00613994175120 (PKK001410R), 00613994581235 (PKK001411R), 00613994581228 (PKK001420R), 00613994136527 (PKK001421R), 00613994136527 (PKK001422R), 00613994175120 (PKK001425R), 00613994175182 (PKK001431R), 00643169440166 (PKK001433R), 00613994175076 (PKK001437R), 00613994175083 (PKK001444R), 00613994175076 (PKK001448R), 00613994581228 (PKK001454R), 00613994175380 (PKK001459R), 00613994175380 (PKK001460R), 00613994175090 (PKK001473R), 00613994175083 (PKK001474R), 00613994175106 (PKK001476R), 00613994136527 (PKK001480R), 00613994581075 (PKK001484R), 00613994175212 (PKK001485R), 00613994175120 (PKK001487R), 00613994175106 (PKK001488R), 00613994175397 (PKK001489R), 00613994175212 (PKK001490R), 00613994175106 (PKK001494R), 00721902246241 (PKK001496R), 00613994175076 (PKK001497R), 00721902246227 (PKK001503R), 00643169537828 (PKK001506R), 00613994175083 (PKK001510R), 00613994581235 (PKK001511R), 00721902246241 (PKK001519R), 00613994581013 (PKK001520R), 00613994175120 (PKK001524R), 00613994175212 (PKK001525R), 00613994581235 (PKK001531R), 00721902246234 (PKK001532R), 00613994175106 (PKK001533R), 00721902246234 (PKK001539R), 00721902246234 (PKK001541R), 00613994136527 (PKK001542R), 00613994581594 (PKK001550R), 00721902246234 (PKK001551R), 00613994581013 (PKK001555R), 00613994175397 (PKK001556R), 00613994581075 (PKK001561R), 00721902246234 (PKK001562R), 00613994136527 (PKK001563R), 00613994175120 (PKK001568R), 00721902246234 (PKK001569R), 00613994581174 (PKK001582R), 00613994175212 (PKK001591R), 00613994136527 (PKK001596R), 00721902246234 (PKK001601R), 00721902246234 (PKK001602R), 00613994175120 (PKK001603R), 00613994175120 (PKK001607R), 00613994581174 (PKK001609R), 00721902246241 (PKK001611R), 00613994136534 (PKK001612R), 00613994581235 (PKK001613R), 00613994175083 (PKK001627R), 00643169537828 (PKK001631R), 00613994175083 (PKK001632R), 00613994581174 (PKK001636R), 00613994175106 (PKK001640R), 00613994175212 (PKK001646R), 00613994175106 (PKK001647R), 00613994175120 (PKK001648R), 00721902246241 (PKK001649R), 00613994581013 (PKK001653R), 00613994581075 (PKK001660R), 00721902246234 (PKK001669R), 00613994175106 (PKK001670R), 00613994175083 (PKK001672R), 00721902246234 (PKK001673R), 00613994175120 (PKK001679R), 00721902246234 (PKK001680R), 00613994175397 (PKK001681R), 00613994175106 (PKK001684R), 00613994581594 (PKK001696R), 00613994175120 (PKK001699R), 00613994136534 (PKK001705R), 00613994580863 (PKK001707R), 00643169537828 (PKK001716R), 00613994580894 (PKK001719R), 00613994175106 (PKK001721R), 0061399417539
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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