Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.
FDA Recall Z-0725-2018 · Posted None
Recalling FirmTerumo Medical Corporation
Recall StatusTerminated
Product CodeDYB
Date Initiated2017-09-12
Date Terminated2018-08-31
Product Quantity33
Reason for Recall
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Firm Action
Terumo sent an Urgent Medical Device Recall dated September 12, 2017 to affected customers. The letter identified the affected product problem and actions to be taken. The informed customers that a territory managers will visit each institution to examine the inventory, identify the affected product and lot, and prepare the product for return to Terumo Medical Corporation. There is an inventory confirmation form that is returned by the sales representative to the recalling site.
Root Cause
Process control
Distribution Pattern
To be added.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.