Ascent Healthcare Solutions
Country not established
- Devices
- 21
- FDA recalls
- 41
At a glance
Market reach
- United States
- FDA recalls
What Ascent Healthcare Solutions makes
Ascent Healthcare Solutions manufactures reprocessed single-use medical devices, including bidirectional diagnostic electrophysiology catheters, external fixation devices, diagnostic and 3D ultrasound catheters, electrosurgical instruments, trocars, and hand-activated sealers/dividers. Their portfolio also covers cardiac stabilization and positioning devices, ultrasonic curved shears with torque and grip assist, and reprocessed Medtronic-branded components.
The company’s devices are regulated under FDA 510(k) clearance requirements, spanning Class I, Class II, and Unclassified (U) risk categories. Their products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Search and filter all 21 devicesFDA recalls
FDA recall records list 41 recalls initiated by Ascent Healthcare Solutions, the earliest on 2006-10-19 and the most recent on 2010-06-23. By recorded status: 41 terminated. The reasons filed fall into these groups: sterility or contamination, packaging, mechanical integrity 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.
2010
- 23 Jun 2010 Z-2196-2010 Unclassified (pre-2012) Terminated The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated.
2009
- 26 Jan 2009 Z-0947-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0948-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0949-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0950-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0951-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0952-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0953-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0954-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0955-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0947-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Show the 25 most recent of 41 recalls
2009
- 26 Jan 2009 Z-0956-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0957-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0958-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0959-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0960-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0961-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0962-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
Full distribution text
- 26 Jan 2009 Z-0956-2012 Unclassified (pre-2012) Terminated On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray.
2008
- 11 Mar 2008 Z-1661-2008 Unclassified (pre-2012) Terminated Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 11 Mar 2008 Z-1662-2008 Unclassified (pre-2012) Terminated Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 11 Mar 2008 Z-1663-2008 Unclassified (pre-2012) Terminated Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 11 Mar 2008 Z-1664-2008 Unclassified (pre-2012) Terminated Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 11 Mar 2008 Z-1665-2008 Unclassified (pre-2012) Terminated Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 11 Mar 2008 Z-1666-2008 Unclassified (pre-2012) Terminated Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 11 Mar 2008 Z-1667-2008 Unclassified (pre-2012) Terminated Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 11 Mar 2008 Z-1668-2008 Unclassified (pre-2012) Terminated Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
Frequently asked questions
How many devices does Ascent Healthcare Solutions have in the registry?
The registry currently lists 21 devices for Ascent Healthcare Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ascent Healthcare Solutions's devices?
Among its 21 most recently registered devices, Ascent Healthcare Solutions has devices listed in FDA 510(k) (21 devices).
What risk classes do Ascent Healthcare Solutions's devices fall under?
Among its 21 most recently registered devices, the classes recorded for Ascent Healthcare Solutions's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ascent Healthcare Solutions?
FDA recall records list 41 recalls initiated by Ascent Healthcare Solutions, the most recent initiated on 2010-06-23. 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 Ascent Healthcare Solutions in the registry?
The most recently registered devices listed for Ascent Healthcare Solutions include REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, REPROCESSED EXTERNAL FIXATION DEVICE, REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER and REPROCESSED ELECTROSURGICAL INSTRUMENT.