Cobe Cardiovascular, Inc.
United StatesFDA applicant, unverified
- Devices
- 43
- FDA recalls
- 21
At a glance
Market reach
- United States
- FDA recalls
What Cobe Cardiovascular, Inc. makes
Cobe Cardiovascular, Inc. manufactures blood salvage systems, including the COBE BRAT 2 Autologous Blood Salvage System with options like the Crit-Line hematocrit sampling system and modified plasma recovery programs. Their portfolio also includes membrane oxygenators such as the SMARXT Optima XP and OptimIN, as well as arterial filters like the Sentry SMARXT 43 micron filter with PrimeGard. Additional products cover heat exchangers for cardiac devices, venous femoral cannulae (Stockert V172 series), and patient monitoring solutions, along with processing sets for blood salvage systems.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) premarket notification database. The manufacturer is based in the United States.
Catalogue
Search and filter all 43 devicesFDA recalls
FDA recall records list 21 recalls initiated by Cobe Cardiovascular, Inc., the earliest on 2003-05-09 and the most recent on 2006-08-04. By recorded status: 21 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 4 Aug 2006 Z-1488-06 Unclassified (pre-2012) Terminated Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
- 4 Aug 2006 Z-1489-06 Unclassified (pre-2012) Terminated Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
- 4 Aug 2006 Z-1490-06 Unclassified (pre-2012) Terminated Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
- 4 Aug 2006 Z-1491-06 Unclassified (pre-2012) Terminated Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
- 26 Jun 2006 Z-1422-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 26 Jun 2006 Z-1423-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 26 Jun 2006 Z-1424-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 26 Jun 2006 Z-1425-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 26 Jun 2006 Z-1426-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 26 Jun 2006 Z-1427-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
Show all 21 recalls
2006
- 26 Jun 2006 Z-1428-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 26 Jun 2006 Z-1429-06 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 26 Jun 2006 Z-1428-06 Unclassified (pre-2012) Terminated 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.
2005
- 6 Oct 2005 Z-0265-06 Unclassified (pre-2012) Terminated One way valve in the heart lung pack assembly may be missing.
- 22 Jun 2005 Z-1069-05 Unclassified (pre-2012) Terminated Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
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- 22 Jun 2005 Z-1070-05 Unclassified (pre-2012) Terminated Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
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- 22 Jun 2005 Z-1071-05 Unclassified (pre-2012) Terminated Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
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- 22 Jun 2005 Z-1072-05 Unclassified (pre-2012) Terminated Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
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- 22 Jun 2005 Z-1073-05 Unclassified (pre-2012) Terminated Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
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- 22 Jun 2005 Z-1074-05 Unclassified (pre-2012) Terminated Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
Full distribution text
2004
- 25 May 2004 Z-1009-04 Unclassified (pre-2012) Terminated Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
2003
- 9 May 2003 Z-0960-03 Unclassified (pre-2012) Terminated Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
Frequently asked questions
How many devices does Cobe Cardiovascular, Inc. have in the registry?
The registry currently lists 43 devices for Cobe Cardiovascular, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cobe Cardiovascular, Inc.'s devices?
Among its 43 most recently registered devices, Cobe Cardiovascular, Inc. has devices listed in FDA 510(k) (43 devices).
What risk classes do Cobe Cardiovascular, Inc.'s devices fall under?
Among its 43 most recently registered devices, the classes recorded for Cobe Cardiovascular, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cobe Cardiovascular, Inc.?
FDA recall records list 21 recalls initiated by Cobe Cardiovascular, Inc., the most recent initiated on 4 Aug 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cobe Cardiovascular, Inc. in the registry?
The most recently registered devices listed for Cobe Cardiovascular, Inc. include COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION, HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA, COBE PATIENT MONITORING PRODUCTS and COBE SAMPLING SITE.