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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 2 of 9

Device	Model / Reference	Registries	Class	Status
Solopath	STFI-1625	FDA UDI	Class II	Unknown
Destination	RSP01	FDA UDI	Class II	Active
Destination	54-74506	FDA UDI	Class II	Active
Glidesheath Slender	80-1670	FDA UDI	Class II	Active
Angio-Seal	C610135	FDA UDI	Class III	Unknown
Glidesheath Slender	50-1070	FDA UDI	Class II	Active
R2P Destination Slender	GS-R6ST1C10W	FDA UDI	Class II	Active
Glidesheath	35-1060	FDA UDI	Class II	Active
Pinnacle	RSS106	FDA UDI	Class II	Active
Destination	54-84501	FDA UDI	Class II	Active
Pinnacle	RSS501	FDA UDI	Class II	Active
Glidesheath Slender	80-1050	FDA UDI	Class II	Active
Pinnacle	10-2534	FDA UDI	Class II	Active
Pinnacle	RSS606	FDA UDI	Class II	Active
Pinnacle Precision Access System	70-5165	FDA UDI	Class II	Active
Destination	RSR20	FDA UDI	Class II	Active
Pinnacle	RSS503	FDA UDI	Class II	Active
Pinnacle	RSS803	FDA UDI	Class II	Active
Glidesheath Slender Tibial Pedal Kit	51-1050	FDA UDI	Class II	Active
Destination	RSR01	FDA UDI	Class II	Active
Pinnacle Precision Access System	70-5130	FDA UDI	Class II	Active
Destination	RSR04	FDA UDI	Class II	Active
Pinnacle	RSS804	FDA UDI	Class II	Active
Pinnacle	RSS601	FDA UDI	Class II	Active
Destination	54-54503	FDA UDI	Class II	Active
Pinnacle	RSB512	FDA UDI	Class II	Active
Solopath	STFI-1425	FDA UDI	Class II	Unknown
Tr Band	TRB29-LRG	FDA UDI	Class II	Active
Pinnacle	RSB403	FDA UDI	Class II	Active
Pinnacle	RSB602	FDA UDI	Class II	Active
Glidesheath	20-1055	FDA UDI	Class II	Active
Glidesheath	30-1045	FDA UDI	Class II	Active
Glidesheath Slender	50-1060	FDA UDI	Class II	Active
Destination	RSC04	FDA UDI	Class II	Active
Pinnacle	RSB511	FDA UDI	Class II	Active
Glidesheath Slender	60-1650	FDA UDI	Class II	Active
Glidesheath	20-2550	FDA UDI	Class II	Active
Pinnacle	RSB711	FDA UDI	Class II	Active
Glideaccess	RSM07	FDA UDI	Class II	Active
Pinnacle	RSS102	FDA UDI	Class II	Active
Pinnacle	RSB802	FDA UDI	Class II	Active
R2p Navicross	SC-R35STR200	FDA UDI	Class II	Active
Pinnacle	RSS404	FDA UDI	Class II	Active
Glidesheath	20-1050	FDA UDI	Class II	Active
Destination	RSR19	FDA UDI	Class II	Active
Glidesheath Slender	60-1075	FDA UDI	Class II	Active
Destination	RSR11	FDA UDI	Class II	Active
Pinnacle	RSS103	FDA UDI	Class II	Active
Pinnacle	10-2031	FDA UDI	Class II	Active
Solopath	STFI-1435	FDA UDI	Class II	Unknown

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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