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Class 1 Recall Issued for Langston V2 Catheters

Destiny Baker2 years ago

Vascular Solutions has issued a Class 1 recall for its Langston V2 dual-lumen catheters after determining that the device's inner catheter can separate.

About the Langston V2 Catheters

According to MassDevice, the recall includes devices manufactured between January and April of 2014 and distributed between March and May of 2014.

Vascular Solutions received several reports that the inner catheter of the recalled devices separated from the device hub during medical imaging tests and procedures to measure intra-vascular pressure.

Class 1 recalls are reserved for devices that could cause serious injury or death and are the U.S. Food and Drug Administration’s highest-risk designation.

Affected Lot Numbers

Lot numbers included in the recall include:

  • 569436
  • 569437
  • 569962
  • 569963
  • 569964
  • 569965
  • 570177
  • 570178
  • 570337
  • 570338
  • 570339
  • 570340
  • 570341
  • 570504
  • 570505
  • 570506
  • 570507
  • 570592
  • 570593
  • 570674
  • 570675
  • 570744
  • 570745
  • 570746
  • 570836
  • 570926
  • 570927
  • 570928
  • 570929
  • 571099
  • 571100
  • 571101
  • 571102
  • 571103
  • 571350
  • 571412
  • 571413
  • 571414
  • 571415
  • 571727

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