Guidant Corp.
Also registered as Guidant Corporation
United StatesFDA applicant, unverified
- Devices
- 89
- FDA recalls
- 42
At a glance
Market reach
- United States
- FDA recalls
What Guidant Corp. makes
Guidant Corp. manufactures biliary and peripheral vascular devices, including modified biliary stent systems, high-torque guide wires with hydrophilic coatings, and embolectomy protection systems. Their portfolio also covers endoscopes with extended lengths and dissection tips, as well as peripheral dilatation catheters designed for vascular interventions.
The company’s devices are regulated under FDA Class II and Class III classifications, with submissions recorded in the 510(k) and PMA registries. The manufacturer is based in the United States.
Catalogue
Search and filter all 89 devicesShowing 1-50 of 89
FDA recalls
FDA recall records list 42 recalls initiated by Guidant Corp., the earliest on 2005-06-13 and the most recent on 2006-09-30. By recorded status: 42 terminated. The reasons filed fall into these groups: electrical or power, 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.
2006
- 30 Sep 2006 Z-0269-2007 Unclassified (pre-2012) Terminated Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
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- 19 May 2006 Z-0002-2007 Unclassified (pre-2012) Terminated Final software load did not occur prior to shipment of select programmers.
- 15 May 2006 Z-1192-06 Unclassified (pre-2012) Terminated Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping.
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- 15 May 2006 Z-1193-06 Unclassified (pre-2012) Terminated Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping.
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- 15 May 2006 Z-1194-06 Unclassified (pre-2012) Terminated Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping.
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- 7 Apr 2006 Z-0825-06 Unclassified (pre-2012) Terminated 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.
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- 7 Apr 2006 Z-0826-06 Unclassified (pre-2012) Terminated 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.
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- 7 Apr 2006 Z-0827-06 Unclassified (pre-2012) Terminated 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.
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- 7 Apr 2006 Z-0828-06 Unclassified (pre-2012) Terminated 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.
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- 11 Mar 2006 Z-0863-06 Unclassified (pre-2012) Terminated Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.
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- 30 Sep 2006 Z-0269-2007 Unclassified (pre-2012) Terminated Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
Show the 25 most recent of 42 recalls
2005
- 30 Sep 2005 Z-0890-06 Unclassified (pre-2012) Terminated Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
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- 30 Sep 2005 Z-0891-06 Unclassified (pre-2012) Terminated Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
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- 30 Sep 2005 Z-0892-06 Unclassified (pre-2012) Terminated Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
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- 22 Sep 2005 Z-0187-06 Unclassified (pre-2012) Terminated A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
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- 22 Sep 2005 Z-0188-06 Unclassified (pre-2012) Terminated A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
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- 22 Sep 2005 Z-0189-06 Unclassified (pre-2012) Terminated A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
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- 22 Sep 2005 Z-0190-06 Unclassified (pre-2012) Terminated A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
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- 22 Sep 2005 Z-0191-06 Unclassified (pre-2012) Terminated Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
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- 22 Sep 2005 Z-0192-06 Unclassified (pre-2012) Terminated Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
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- 22 Sep 2005 Z-0193-06 Unclassified (pre-2012) Terminated Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
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- 22 Sep 2005 Z-0194-05 Unclassified (pre-2012) Terminated Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
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- 18 Jul 2005 Z-1032-05 Unclassified (pre-2012) Terminated A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
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- 18 Jul 2005 Z-1033-05 Unclassified (pre-2012) Terminated A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
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- 18 Jul 2005 Z-1034-05 Unclassified (pre-2012) Terminated A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
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- 18 Jul 2005 Z-1035-05 Unclassified (pre-2012) Terminated A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
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- 30 Sep 2005 Z-0890-06 Unclassified (pre-2012) Terminated Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
Frequently asked questions
How many devices does Guidant Corp. have in the registry?
The registry currently lists 89 devices for Guidant Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Guidant Corp.'s devices?
Among its 50 most recently registered devices, Guidant Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Guidant Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Guidant Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Guidant Corp.?
FDA recall records list 42 recalls initiated by Guidant Corp., the most recent initiated on 2006-09-30. 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 Corp. in the registry?
The most recently registered devices listed for Guidant Corp. include ACUITY STEERABLE STYLET ACCESSORY, RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568, MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, and HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING.