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FDA (Device enforcement)Recalled 2019-01-17closedclass ii

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): MEDTRONIC CARELINK 2090 programmer

Is my product affected?

MEDTRONIC CARELINK 2090 programmer

  • UPC 00613994175397
  • UPC 00721902246241
  • UPC 00613994175380
  • UPC 00613994136541
  • UPC 00613994175106
  • UPC 00613994175076
  • UPC 00721902171079
  • UPC 00613994581594
  • UPC 00885074314921
  • UPC 00885074301440
  • UPC 00885074312873
  • UPC 00885074312866
  • UPC 00613994175144
  • UPC 00885074313122
  • UPC 00613994175250
  • UPC 00613994434982
  • UPC 00613994435309
  • UPC 00613994434937
  • UPC 00613994580894
  • UPC 00613994580962
  • UPC 00613994580887
  • UPC 00613994580924
  • UPC 00613994581532
  • UPC 00613994136527
  • UPC 00613994175120
  • UPC 00721902246234
  • UPC 00721902171239
  • UPC 00613994360922
  • UPC 00721902854637
  • UPC 00721902824692
  • UPC 00885074313009
  • UPC 00613994175403
  • UPC 00613994175267
  • UPC 00613994175243
  • UPC 00613994434920
  • UPC 00613994435002
  • UPC 00613994581570
  • UPC 00613994581600
  • UPC 00613994581013
  • UPC 00613994136497

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

What happened

Medtronic is recalling the CareLINK 2090 programmer due to an error in how the device calculates and displays the remaining longevity value during a period of up to 2 years before the device reaches its Recommended Replacement Time (RRT). A total of 33,007 units have been distributed across the United States and multiple international locations, including Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, and the Syrian Arab Republic.

The source document does not specify a remedy or recommended action for affected consumers.

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

Hazard

There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).

Details from the source

Reason for recall: There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT). Distribution: US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic Quantity: 33007 units Lot/code info: UPN Lot Serial # 00613994175397 PKK005256R 00721902246241 PKK005435R 00613994175380 PKK010235R 00613994136541 PKK010864R 00613994175106 PKK010944R 00613994175106 PKK013390R 00613994175076 PKK014053R 00721902171079 PKK014459R 00721902246241 PKK016196R 00613994581594 PKK019007R 00613994175397 PKK053072R 00613994175397 PKK053799R 00885074314921 PKK100200R 00885074301440 PKK100970R 00885074312873 PKK101320R 00885074312866 PKK101390R 00885074312873 PKK101826R 00613994175144 PKK102639R 00885074313122 PKK104915R 00613994175250 PKK106350R 00613994434982 PKK200802R 00613994435309 PKK200982R 00613994435309 PKK201102R 00613994434937 PKK203476R 00613994434937 PKK203505R 00613994580894 PKK204058R 00613994580962 PKK204433R 00613994580887 PKK205733R 00613994580924 PKK205784R 00613994580894 PKK206708R 00613994580962 PKK206741R 00613994580962 PKK206743R 00613994581532 PKK210147R 00613994581532 PKK210150R 00613994581532 PKK210151R 00613994581532 PKK210155R 00613994581532 PKK210158R 00613994581532 PKK210163R 00613994581532 PKK210176R 00613994581532 PKK210181R 00613994581532 PKK210182R 00613994581532 PKK210198R 00613994581532 PKK210214R 00613994581532 PKK210216R 00613994581532 PKK210218R 00613994581532 PKK210220R 00613994581532 PKK210224R 00613994581532 PKK210232R 00613994581532 PKK210237R 00613994136527 PKK001974R 00613994581594 PKK002535R 00613994136527 PKK003022R 00613994175397 PKK003119R 00613994136527 PKK003178R 00613994175397 PKK003609R 00613994175120 PKK003704R 00721902171079 PKK003875R 0

Source

Official record: FDA (Device enforcement) ↗

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

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