Z-1428-06

Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular...

Name: Z-1428-06 Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular...
Creator: Cobe Cardiovascular, Inc
Published: 2006-06-26
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2006-06-26 / Terminated

FDA source

Cobe Cardiovascular, Inc began a recall of Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular, Inc.. (shipped International only for use in... on 2006-06-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1428-06
Status: Terminated
Initiated: 2006-06-26
Posted: 2006-08-24
Terminated: 2011-08-08
Recalling firm: LivaNova USA, Inc.
Product: Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular, Inc.. (shipped International only for use in Heart/Lung packs)
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: 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.
FDA root cause: Other
Action: Consignees were notified by letter on 06/26/2006.
Quantity in commerce: 30 units (Australia)
Distribution: Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan
Product codes and lots: Lot number 0610800082.

Product code DTZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)