Z-2033-2017Class II

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

Name: Z-2033-2017 Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into...
Creator: Terumo Medical Corporation
Published: 2015-11-06
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2015-11-06 / Terminated / root cause: labeling and UDI

FDA source

Terumo Medical Corporation began a recall of Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature on 2015-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2033-2017
Classification: Class II
Status: Terminated
Initiated: 2015-11-06
Posted: 2017-05-04
Terminated: 2017-05-12
Recalling firm: Terumo Medical Corp.
Product: Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Product code: DYB Introducer, Catheter
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: An Urgent Product Bulletin Recall of Terumo Medical Product letter, dated November 6, 2015, was sent to customers. The letter identified the affected product and the reason for the voluntary recall. The letter asked customers to immediately discontinue use and quarantine any of the affected product listed. Customers are to complete the enclosed Contact & Inventory Confirmation Form and e-mail [email protected] or fax to 732-412-4121, Attn: Destination Recall. For questions or further information, customers can contact Customer Care at 800-888-3786 or their local sales representative.
Quantity in commerce: 5,252 eaches
Distribution: Nationwide Distribution.
Product codes and lots: Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2033-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2033-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-04

Product code DYB

K012854Class IIRenal Guiding SheathTerumo Medical Corp. / cleared 2001-11-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)