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Recall Observatory FDA recall evidence

Device product

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

Z-2033-2017

November 06, 2015

Class II

Product summary

Firm
Terumo Medical Corporation
Event
Event 76939
Status
Terminated
Classification
Class II
Quantity
5,252 eaches
Official record key
device-enforcement:Z-2033-2017

Official wording

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.

Code information: Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.