Guidant Corporation, Cardiac Surgery
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Guidant Corporation, Cardiac Surgery makes
The company manufactures devices for cardiac surgery and related procedures, including internal cardioversion systems, harvesting cannulas for vascular applications, proximal seal systems for cardiac tissue, aspiration/irrigation instruments with positioning guides, and microwave ablation systems for tissue treatment. Additional products include dissection cannulas and tips for surgical use.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Syncrus Internal Cardioversion System Ref K020701
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Vasoview 5 Harvesting Cannula Ref K020143
Regimes: 510(k) Registry: 510(k)Heartstring Iii Proximal Seal System Ref K080169
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Guidant Microwave Ablation System Ref K041340
Regimes: 510(k) Registry: 510(k)Guidant Syncrus Internal Cardioversion System Ref K024071
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Guidant Corporation, Cardiac Surgery, the earliest on 2003-11-19 and the most recent on 2006-12-01. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 1 Dec 2006 Z-0611-2007 Unclassified (pre-2012) Terminated Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
Full distribution text
- 1 Dec 2006 Z-0612-2007 Unclassified (pre-2012) Terminated Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
Full distribution text
- 1 Dec 2006 Z-0611-2007 Unclassified (pre-2012) Terminated Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
2005
- 5 Jul 2005 Z-1396-05 Unclassified (pre-2012) Terminated Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device
Full distribution text
- 5 Jul 2005 Z-1396-05 Unclassified (pre-2012) Terminated Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device
2003
- 19 Nov 2003 Z-0292-04 Unclassified (pre-2012) Terminated VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
Full distribution text
- 19 Nov 2003 Z-0292-04 Unclassified (pre-2012) Terminated VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
Frequently asked questions
How many devices does Guidant Corporation, Cardiac Surgery have in the registry?
The registry currently lists 8 devices for Guidant Corporation, Cardiac Surgery. Devices recorded under merged duplicate company entries are counted once.
Which registries list Guidant Corporation, Cardiac Surgery's devices?
Among its 8 most recently registered devices, Guidant Corporation, Cardiac Surgery has devices listed in FDA 510(k) (8 devices).
What risk classes do Guidant Corporation, Cardiac Surgery's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Guidant Corporation, Cardiac Surgery's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Guidant Corporation, Cardiac Surgery?
FDA recall records list 4 recalls initiated by Guidant Corporation, Cardiac Surgery, the most recent initiated on 1 Dec 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 Guidant Corporation, Cardiac Surgery in the registry?
The most recently registered devices listed for Guidant Corporation, Cardiac Surgery include SYNCRUS INTERNAL CARDIOVERSION SYSTEM, VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002, VASOVIEW 5 HARVESTING CANNULA and HEARTSTRING III PROXIMAL SEAL SYSTEM.