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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 9 of 9

Device	Model / Reference	Registries	Class	Status
Terumo Surflo Flex I.v. Catheter And Terumo Surflash I.v. Catheter	K991406	FDA 510(k)	Class II	Active
Terumo Sensibead Eia Hgh Kit	K852299	FDA 510(k)	Class I	Active
Clirans Taf 120 Hollow Fiber Dialyz. &	K831482	FDA 510(k)	Class II	Active
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath	K172995	FDA 510(k)	Class II	Active
Cross-Seal Suture-Mediated Vascular Closure Device System	P210017	FDA PMA	Class III	Active
MISAGO® RX Self-expanding Peripheral Stent	P140002	FDA PMA	Class III	Active
Angio-Seal Vascular Closure Device Sts Plus Platform	P930038	FDA PMA	Class III	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