Class II — Terumo Medical Corporation
| Recalling firm | TERUMO MEDICAL CORP. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The tucking depth feature of this catheter introducer is marginally outside the upper specification. |
| 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. |
| Quantity | 33 |
| Distribution | To be added. |
| Initiated | 2017-09-12 |
| Classified | 2018-02-26 |
| Terminated | 2018-08-31 |
| Recall number | Z-0725-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Terumo Medical Corporation (Z-0725-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79167/
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