Terumo Medical Corporation: Medical Device Recall in 2017 - (Recall #: Z-2033-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 6, 2015

Date Posted: May 10, 2017

Recall Number: Z-2033-2017

Event ID: 76939

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.

Status: Terminated

Product Quantity: 5,252 eaches

Code Information:

Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated