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FDA (Device enforcement)Recalled 2020-01-30class ii

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

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Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

  • UPC 00721902546341
  • UPC 00721902246234
  • UPC 00721902569517
  • UPC 00613994580955
  • UPC 00643169537828
  • UPC 00613994175397
  • UPC 00613994175120
  • UPC 00613994175106
  • UPC 00721902246227
  • UPC 00613994175212
  • UPC 00613994175144
  • UPC 00613994175076
  • UPC 00613994581075
  • UPC 00613994581204
  • UPC 00613994175267
  • UPC 00613994175083
  • UPC 00613994581235
  • UPC 00613994136534
  • UPC 00613994581228
  • UPC 00613994136527
  • UPC 00613994175182
  • UPC 00643169440166
  • UPC 00613994175380
  • UPC 00613994175090
  • UPC 00721902246241
  • UPC 00613994581013
  • UPC 00613994581594
  • UPC 00613994581174
  • UPC 00613994580863
  • UPC 00613994580894
  • UPC 00613994175175
  • UPC 00721902246289
  • UPC 00613994136497
  • UPC 00613994581051
  • UPC 00613994581181
  • UPC 00721902246326
  • UPC 00613994175137
  • UPC 00613994175151
  • UPC 00613994175540
  • UPC 00643169537774

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling approximately 23,180 CareLink 2090 Programmers worldwide due to two cybersecurity vulnerabilities in the Medtronic Conexus Telemetry system. The programmers are used to interrogate and program Medtronic and Vitatron implantable devices such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy devices (CRTs). The vulnerabilities include improper access control and cleartext transmission of sensitive information, which could potentially allow unauthorized access to the device.

The recalled devices were distributed worldwide, including throughout the United States, Puerto Rico, and multiple countries in Central and South America, the Caribbean, Europe, and Japan. The affected product is Model Number 2090 with all serial numbers, and the recall includes specific lot numbers identified by their GTINs and package codes. The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.

Details from the source

Reason for recall: Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information. Distribution: 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, Luxembou Quantity: 23,180 devices Lot/code info: 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), 0061

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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