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Terumo Medical Recalls
39 recalls on record · July 3, 2013 to August 19, 2026 · Medical Devices
Recalls by year
13
15
16
17
18
19
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx
Hazard: 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.
December 20, 2017Medical DevicesFDA
Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx
Hazard: 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.
May 10, 2017Medical DevicesFDA
Terumo Medical Corporation recalls Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the huma
Hazard: 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.
May 10, 2017Medical DevicesFDA
Terumo Medical Corporation recalls SurFlo IV Catheter
Hazard: 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.
December 7, 2016Medical DevicesFDA
Terumo Medical Corp recalls MISAGO RX Self Expanding Peripheral Stem
Hazard: 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.
September 14, 2016Medical DevicesFDA
Terumo Medical Corporation recalls PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R
Hazard: 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.
December 30, 2015Medical DevicesFDA
Terumo Medical Corp recalls Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Hazard: Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
July 3, 2013Medical DevicesFDA
Terumo Medical Corporation recalls Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through
Hazard: Medical devices were incorrectly labeled with extended expiration dates.
July 3, 2013Medical DevicesFDA
Terumo Medical Corporation recalls Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to
Hazard: Medical devices were incorrectly labeled with extended expiration dates.