Refinity Rotational Intravascular Ultrasound — Class II medical device recall Z-1775-2017
Terminated recall by Volcano Corporation, reported 2017-04-19. High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter.
| Recall number | Z-1775-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2017-03-29 |
| Classified | 2017-04-13 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2017-06-21 |
| Countries outside the US | JP |
| Quantity | 718 units |
| Lot numbers | 50068951, 50068952, 50069133, 50083387, 50083390 |
| Model numbers | 89800 |
| Expiration dates | 2018-06-30, 2018-11-30 |
Product
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Reason for recall
High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.
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-1775-2017. 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.