Thomas Medical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 23
- FDA recalls
- 17
At a glance
Market reach
- United States
- FDA recalls
What Thomas Medical Products, Inc. makes
Thomas Medical Products, Inc. manufactures a range of vascular access and procedural introducer systems, including multi-port Y introducers, reinforced catheter introducer systems, and coronary sinus guide kits. Their portfolio also covers hemodialysis introducers, tear-away sheath introducers with hemostasis valves, transseptal needles/trocars, and steerable introducer kits for cardiac procedures. Additional products include percutaneous introducer sets, splittable sheath kits, and specialized crossover adapters for interventional use.
All listed devices fall under Class II regulatory classification in the US, with authorisation via 510(k) premarket notifications through the FDA. The company’s products are registered under the FDA’s 510(k) pathway, ensuring compliance with US medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 23 devicesFDA recalls
FDA recall records list 17 recalls initiated by Thomas Medical Products, Inc., the earliest on 2004-06-11 and the most recent on 2011-10-07. By recorded status: 17 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging 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.
2011
- 7 Oct 2011 Z-0168-2012 Unclassified (pre-2012) Terminated Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube.
2010
- 16 Dec 2010 Z-1225-2011 Unclassified (pre-2012) Terminated Compromised sterility/weak or open seals.
- 16 Dec 2010 Z-1226-2011 Unclassified (pre-2012) Terminated Compromised sterility/weak or open seals.
- 16 Dec 2010 Z-1227-2011 Unclassified (pre-2012) Terminated Compromised sterility/weak or open seals.
- 16 Dec 2010 Z-1228-2011 Unclassified (pre-2012) Terminated Compromised sterility/weak or open seals.
- 1 Feb 2010 Z-0815-2010 Unclassified (pre-2012) Terminated Radiopaque tip may fracture
2009
- 17 Dec 2009 Z-0661-2010 Unclassified (pre-2012) Terminated Radiopaque sheath tip may fracture
- 21 Oct 2009 Z-0120-2010 Unclassified (pre-2012) Terminated Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
2008
- 12 Sep 2008 Z-0131-2009 Unclassified (pre-2012) Terminated Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.
2005
- 7 Nov 2005 Z-0297-06 Unclassified (pre-2012) Terminated mislabeled as 9.5F actually contains 10.5F
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- 7 Nov 2005 Z-0297-06 Unclassified (pre-2012) Terminated mislabeled as 9.5F actually contains 10.5F
Show all 17 recalls
2004
- 14 Oct 2004 Z-0056-05 Unclassified (pre-2012) Terminated Sheaths may fracture if exposed to excess fluorescent light
- 14 Oct 2004 Z-0057-05 Unclassified (pre-2012) Terminated Sheaths may fracture if exposed to excess fluorescent light
- 14 Oct 2004 Z-0058-05 Unclassified (pre-2012) Terminated Sheaths may fracture if exposed to excess fluorescent light
- 11 Jun 2004 Z-1085-04 Unclassified (pre-2012) Terminated Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
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- 11 Jun 2004 Z-1086-04 Unclassified (pre-2012) Terminated Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
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- 11 Jun 2004 Z-1087-04 Unclassified (pre-2012) Terminated Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
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- 11 Jun 2004 Z-1088-04 Unclassified (pre-2012) Terminated Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
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Frequently asked questions
How many devices does Thomas Medical Products, Inc. have in the registry?
The registry currently lists 23 devices for Thomas Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Thomas Medical Products, Inc.'s devices?
Among its 23 most recently registered devices, Thomas Medical Products, Inc. has devices listed in FDA 510(k) (23 devices).
What risk classes do Thomas Medical Products, Inc.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for Thomas Medical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Thomas Medical Products, Inc.?
FDA recall records list 17 recalls initiated by Thomas Medical Products, Inc., the most recent initiated on 7 Oct 2011. 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 Thomas Medical Products, Inc. in the registry?
The most recently registered devices listed for Thomas Medical Products, Inc. include MULTI-PORT Y INTRODUCER SET, REINFORCED CATHETER INTRODUCER SYSTEM (RCIS), CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS and LONG LENGTH PERCUTANEOUS INTRODUCER SET.