Z-0725-2018Class II

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06

Name: Z-0725-2018 Destination Guiding Sheath catheter introducer, Catalog Number: RSR06
Creator: Terumo Medical Corporation
Published: 2017-09-12
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2017-09-12 / Terminated / root cause: manufacturing process

FDA source

Terumo Medical Corporation began a recall of Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination Guiding Sheath is designed to be used for the introduction... on 2017-09-12. FDA classified it as Class II and gives the reason as "The tucking depth feature of this catheter introducer is marginally outside the upper specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0725-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-12
Posted: 2018-02-26
Terminated: 2018-08-31
Recalling firm: Terumo Medical Corp.
Product: 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.
Product code: DYB Introducer, Catheter
Reason for recall: The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 33
Distribution: To be added.
Product codes and lots: Lot: VK09, Expiration Date: 31-Jan-2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0725-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0725-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-26

Product code DYB

K012584Class IIModification to: Bd Durasafe Plus Epidural Lock Cse Needle Set/kitBd / cleared 2001-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)