Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.

Recall Insight

This FDA Devices action (record #Z-2033-2017) was formally reported on May 10, 2017, with the manufacturer initiating the action on November 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Medical Corporation is listed as the recalling firm, operating out of Elkton, MD. Federal records indicate 5,252 eaches units are affected.

The documented reason for this recall is: 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 patie… Distribution data in the federal record shows the product reached: Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.