Destination Renal Guiding Sheath Intended for the introduction of… — Class II medical device recall Z-2033-2017
Terminated recall by Terumo Medical Corporation, reported 2017-05-10, distributed nationwide. Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Des
| Recall number | Z-2033-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corporation, Elkton, MD, United States |
| Recall initiated | 2015-11-06 |
| Classified | 2017-05-04 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2017-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 5,252 eaches |
| Reason classes | labeling |
| Lot numbers | RN19, RN26, RP03 |
Product
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2033-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.