Cobe Smarxt Tubing and Connectors

• • Terminated Z-1389-2020 FDA Class III ·initiated 3 Jul 2019

  Perfusion tubing pack was packaged with the incorrect cuvette.

• • Terminated Z-0664-2018 FDA Class III ·initiated 19 Dec 2017

  The product is labeled with the incorrect expiration date.

• 16 recalls, same reason

  • Terminated Z-2789-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2795-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2784-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2798-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2797-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2786-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2791-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2794-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2793-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2788-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2796-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2783-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2785-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2792-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2787-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-2790-2017 FDA Class II ·initiated 29 Jun 2017

  Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

510(k) Number

K981613 ↗

FDA Product Code

DWE

Device Class

Class II

Regulation

21 CFR Part 870.4390

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cobe Brat 2 Autologous Blood Salvage System With Crit-Line Hematocrit Sampling System

  Class II

  FDA 510(k) K991986 Active Cleared 9 Sep 1999

• Heat Exchanger Modification for Duo and Optima

  Class II

  FDA 510(k) K944267 Active Cleared 28 Apr 1995

• Cobe Patient Monitoring Products

  Class II

  FDA 510(k) K921343 Active Cleared 5 Jan 1993

• Cobe Sampling Site

  Class II

  FDA 510(k) K922484 Active Cleared 3 Dec 1992

• Cobe Cms-Fs Membrane Oxygenator

  Class II

  FDA 510(k) K926467 Active Cleared 9 Nov 1993

• Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator

  Class II

  FDA 510(k) K000255 Active Cleared 25 Apr 2000

See all devices from Cobe Cardiovascular, Inc. →