Destination Guiding Sheath catheter introducer — Class II medical device recall Z-0725-2018
Terminated recall by Terumo Medical Corporation, reported 2018-03-07. The tucking depth feature of this catheter introducer is marginally outside the upper specification.
| Recall number | Z-0725-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corporation, Elkton, MD, United States |
| Recall initiated | 2017-09-12 |
| Classified | 2018-02-26 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-08-31 |
| Quantity | 33 |
| Lot numbers | VK09 |
| Model numbers | RSR06 |
| Expiration dates | 2020-01-31 |
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.
Reason for recall
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
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-0725-2018. 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.