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TERUMO MEDICAL CORPORATION

Last updated September 17, 2026

Information

Country: US
Address: 265 Davidson Ave, Somerset, NJ, 08873
Website: terumomedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)283-7866
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2243441
DUNS Number: 131489882

Catalogue (407)

Page 1 of 9

Device	Model / Reference	Registries	Class	Status
Destination	54-86501	FDA UDI	Class II	Active
Destination	RSR15	FDA UDI	Class II	Active
Destination	RSC08	FDA UDI	Class II	Active
Destination	RSR12	FDA UDI	Class II	Active
Pinnacle	RSB801	FDA UDI	Class II	Active
Glidesheath	40-1650	FDA UDI	Class II	Active
Pinnacle	RSS602	FDA UDI	Class II	Active
Pinnacle	10-2034	FDA UDI	Class II	Active
Destination	RSC02	FDA UDI	Class II	Active
Glidesheath	40-2550	FDA UDI	Class II	Active
Destination	RSR02	FDA UDI	Class II	Active
Glidesheath	40-1060	FDA UDI	Class II	Active
Solopath	STFI-1825	FDA UDI	Class II	Unknown
Pinnacle	RSS004	FDA UDI	Class II	Active
Pinnacle	RSS001	FDA UDI	Class II	Active
Solopath	STFI-2135	FDA UDI	Class II	Unknown
Glideaccess	RSM03	FDA UDI	Class II	Active
Solopath	SR-1935	FDA UDI	Class II	Unknown
Glidesheath Slender	60-1660	FDA UDI	Class II	Active
Glidesheath Slender	60-1070	FDA UDI	Class II	Active
Pinnacle	RSB611	FDA UDI	Class II	Active
Glidesheath	35-2560	FDA UDI	Class II	Active
Pinnacle	RSB803	FDA UDI	Class II	Active
Pinnacle Precision Access System	70-5160	FDA UDI	Class II	Active
Pinnacle	RSB903	FDA UDI	Class II	Active
Pinnacle	10-2033	FDA UDI	Class II	Active
Glideaccess	RSM05	FDA UDI	Class II	Active
Destination	RSR08	FDA UDI	Class II	Active
Destination	54-84506	FDA UDI	Class II	Active
Pinnacle	RSS603	FDA UDI	Class II	Active
Glidesheath	30-1040	FDA UDI	Class II	Active
Pinnacle	RSB502	FDA UDI	Class II	Active
Pinnacle	RSB805H	FDA UDI	Class II	Active
Pinnacle	RSS005	FDA UDI	Class II	Active
Solopath	STFI-1925	FDA UDI	Class II	Unknown
Pinnacle	RSS505	FDA UDI	Class II	Active
Glideaccess	RSM04	FDA UDI	Class II	Active
Destination	RSR14	FDA UDI	Class II	Active
Pinnacle	RSB703	FDA UDI	Class II	Active
Pinnacle	RSB712	FDA UDI	Class II	Active
Destination	RSR18	FDA UDI	Class II	Active
R2P Destination Slender	GS-R6ST1C75W	FDA UDI	Class II	Active
Pinnacle	RSB603	FDA UDI	Class II	Active
Destination	54-54502	FDA UDI	Class II	Active
Glidesheath	40-1660	FDA UDI	Class II	Active
Pinnacle	RSB911	FDA UDI	Class II	Active
Pinnacle	RSS105	FDA UDI	Class II	Active
Pinnacle	RSS901	FDA UDI	Class II	Active
Glidesheath Slender	60-1060	FDA UDI	Class II	Active
Pinnacle	RSB912	FDA UDI	Class II	Active

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FDA Recalls (43)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 26, 2019	Z-1374-2019	—	terminated	There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Apr 26, 2019	Z-1376-2019	—	terminated	There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Apr 26, 2019	Z-1375-2019	—	terminated	There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Feb 8, 2019	Z-2003-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Feb 8, 2019	Z-2004-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Feb 8, 2019	Z-1998-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Feb 8, 2019	Z-2001-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Feb 8, 2019	Z-2000-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Feb 8, 2019	Z-2005-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Feb 8, 2019	Z-1999-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Feb 8, 2019	Z-2002-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Feb 8, 2019	Z-2006-2019	—	terminated	There is a potential for a loss of package integrity that may compromise the sterility of the product.
Apr 9, 2018	Z-2337-2018	—	terminated	Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
Sep 12, 2017	Z-0725-2018	—	terminated	The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Jun 7, 2017	Z-0224-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0218-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0226-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0215-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0220-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0221-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0214-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0223-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0228-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0227-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0230-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0225-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0219-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0229-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0217-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0222-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Jun 7, 2017	Z-0216-2018	—	terminated	An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Aug 4, 2016	Z-0669-2017	—	terminated	During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.
Mar 16, 2016	Z-2738-2016	—	terminated	Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
Nov 23, 2015	Z-0551-2016	—	terminated	Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
Nov 6, 2015	Z-2033-2017	—	terminated	Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Aug 5, 2015	Z-1896-2017	—	terminated	According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.
May 30, 2013	Z-1612-2013	—	terminated	Medical devices were incorrectly labeled with extended expiration dates.
May 30, 2013	Z-1611-2013	—	terminated	Medical devices were incorrectly labeled with extended expiration dates.
Jun 3, 2011	Z-2858-2011	—	terminated	Baloon catheter guidewires may become uncoiled during angioplasty procedures.
Jun 24, 2010	Z-2415-2011	—	terminated	Molding defect in destination product that render the device unusable.
Jun 24, 2010	Z-2417-2011	—	terminated	Molding defect in destination product that render the device unusable.
Jun 24, 2010	Z-2416-2011	—	terminated	Molding defect in destination product that render the device unusable.
Jun 8, 2010	Z-2798-2011	—	terminated	Hypodermic needle packaging defect could compromise sterility. Affected lot numbers are: MC1725, MC2025, MC2025