Recall Z-2033-2017— Terumo Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Medical Corporation, initiated 2015-11-06, terminated 2017-05-12. It names one FDA 510(k) clearance: K012854. Product: Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.. Reason: 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..
- Recalling firm
- Terumo Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-06
- Terminated
- 2017-05-12
- Firm location
- Elkton, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.