Back to search
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

Sell products like this?

Recalert watches your whole catalog for recalls like this one, automatically.

Start free — no card