Spire Biomedical, Inc.
United StatesFDA applicant, unverified
- Devices
- 16
- FDA recalls
- 48
At a glance
Market reach
- United States
- FDA recalls
What Spire Biomedical, Inc. makes
Spire Biomedical, Inc. manufactures hemodialysis catheters, including twin lumen designs with separated tips, coated and funnel-tipped variants, and specialized kits for sheathless access. Their portfolio includes chronic and acute use catheters in varying French sizes and lengths, such as the Decathlon Gold, Alta Gold, and Pourchez Retro Safe Trac models. Additional accessories like repair kits and expresso twin lumen catheters are also part of their offerings.
All listed devices fall under Class II regulatory classification in the U.S. and are recorded in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 48 recalls initiated by Spire Biomedical, Inc., initiated on 2009-10-23. By recorded status: 48 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.
2009
- 23 Oct 2009 Z-0288-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0289-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0290-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0291-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0292-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0293-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0294-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0295-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0296-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0297-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
Show the 25 most recent of 48 recalls
2009
- 23 Oct 2009 Z-0298-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0299-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0300-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0301-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0302-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0303-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0304-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0305-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0306-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0307-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0308-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0309-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0310-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0311-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- 23 Oct 2009 Z-0312-2010 Unclassified (pre-2012) Terminated There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
Frequently asked questions
How many devices does Spire Biomedical, Inc. have in the registry?
The registry currently lists 16 devices for Spire Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spire Biomedical, Inc.'s devices?
Among its 16 most recently registered devices, Spire Biomedical, Inc. has devices listed in FDA 510(k) (16 devices).
What risk classes do Spire Biomedical, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Spire Biomedical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Spire Biomedical, Inc.?
FDA recall records list 48 recalls initiated by Spire Biomedical, Inc., the most recent initiated on 23 Oct 2009. 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 Spire Biomedical, Inc. in the registry?
The most recently registered devices listed for Spire Biomedical, Inc. include DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH, RETRO REPAIR KIT, MODEL PRRK5, DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, and 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55.