Heartport, Inc.
United StatesFDA applicant, unverified
- Devices
- 24
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Heartport, Inc. makes
Heartport, Inc. manufactures minimally invasive surgical instruments and devices for cardiac and thoracic procedures, including arterial cannulas, endovascular catheters, trocars, introducer sheaths, endoaortic clamps, and cryoprobe sets for atrial ablation. Their portfolio also includes kits for percutaneous access, such as softclamp and StraightShot configurations, as well as endopulmonary vent systems for temporary lung support during surgery.
The company’s devices are classified under FDA’s Class II regulatory category and are listed via the 510(k) premarket notification process. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Search and filter all 24 devicesFDA recalls
FDA recall records list 6 recalls initiated by Heartport, Inc., the earliest on 2003-10-02 and the most recent on 2005-04-12. By recorded status: 6 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 12 Apr 2005 Z-0811-05 Unclassified (pre-2012) Terminated Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
Full distribution text
- 12 Apr 2005 Z-0811-05 Unclassified (pre-2012) Terminated Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
2003
- 2 Oct 2003 Z-0307-04 Unclassified (pre-2012) Terminated Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
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- 2 Oct 2003 Z-0308-04 Unclassified (pre-2012) Terminated Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
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- 2 Oct 2003 Z-0309-04 Unclassified (pre-2012) Terminated Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
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- 2 Oct 2003 Z-0310-04 Unclassified (pre-2012) Terminated Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
Full distribution text
- 2 Oct 2003 Z-0311-04 Unclassified (pre-2012) Terminated Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
Full distribution text
- 2 Oct 2003 Z-0307-04 Unclassified (pre-2012) Terminated Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
Frequently asked questions
How many devices does Heartport, Inc. have in the registry?
The registry currently lists 24 devices for Heartport, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heartport, Inc.'s devices?
Among its 24 most recently registered devices, Heartport, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Heartport, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Heartport, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Heartport, Inc.?
FDA recall records list 6 recalls initiated by Heartport, Inc., the most recent initiated on 12 Apr 2005. 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 Heartport, Inc. in the registry?
The most recently registered devices listed for Heartport, Inc. include DIRECTFLOW ARTERIAL CANNULA, HEARTPORT ENDOSINUS CATHETER, HEARTPORT NEEDLE TROCAR and HEARTPORT ENDOPULMONARY VENT CATHETER.