FDA Device recall Z-2033-2017
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature
- FDA Device
- Class II
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class II recall of Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature by Terumo Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2033-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-06 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Medical |
| Distribution | US |
Product
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
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.
Identifiers
| code_info | Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Terumo Medical
- GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box
FDA Device · Class II · 2026-08-19 · Terumo Medical - Terumo Needle, 30G x 1/2", Product Code NN3013R
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
FDA Device · Class II · 2019-07-31 · Terumo Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2033-2017%22
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