Cobe(R) Cml Duo(R) with Smart(Tm) Surface Modified Membrance Oxygenator

• 2 recalls, same reason

  • Terminated Z-1425-06 FDA Unclassified (pre-2012) ·initiated 26 Jun 2006
  • Terminated Z-1422-06 FDA Unclassified (pre-2012) ·initiated 26 Jun 2006

  Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.

510(k) Number

K974812 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K991986 Active Cleared 9 Sep 1999

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See all devices from Cobe Cardiovascular, Inc. →

• What is the Cobe CML Duo With Smart Surface Modified Membrane Oxygenator used for?

  This device is designed for cardiopulmonary bypass procedures, where it oxygenates and decarboxylates blood during extracorporeal circulation. It supports cardiac surgery and other procedures requiring temporary circulatory assistance by facilitating gas exchange in the bloodstream.

• Is the Cobe CML Duo With Smart Surface Modified Membrane Oxygenator single-use or reusable?

  The device is supplied as a single-use, sterile medical product. This ensures patient safety by preventing cross-contamination and maintaining consistent performance for each procedure.

• What makes the Smart Surface technology on this oxygenator beneficial?

  The Smart Surface technology modifies the membrane to improve biocompatibility, reducing the risk of blood clotting (thrombogenic risks) during use. This enhancement helps minimize complications and supports safer patient outcomes during cardiopulmonary bypass.

• How should the Cobe CML Duo With Smart Surface Modified Membrane Oxygenator be stored?

  The device must be stored following standard sterile medical device protocols to preserve its integrity until use. This includes maintaining proper packaging, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions.

• Is this oxygenator compatible with standard cardiopulmonary bypass systems?

  Yes, the Cobe CML Duo With Smart Surface Modified Membrane Oxygenator is designed to be compatible with standard cardiopulmonary bypass systems. It is also non-magnetic, meaning it does not interfere with MRI environments or require special handling for magnetic resonance imaging.