Refinity Short Tip Rotational Intravascular Ultrasound… recallZ-1776-2017 · Volcano Corporation · initiated Mar 29, 2017
Class II Terminated All recalls posted in April 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Volcano Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Recall letters dated March 28, 2017 will be hand delivered by Volcano reps. Reps will also pick up any unused catheters for return and obtain a signed proof of delivery for both customer and Volcano Rep.
Recall details
- Recall number
- Z-1776-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 29, 2017
- Posted by the FDA
- Apr 10, 2017
- Recalling firm
- Volcano Corporation
- Quantity
- 718 total devices
- Product code
- OBJ
- FDA submissions
- K160583
- Distribution
- Distribution to US and Japan
Product description
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. 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.
Code information (models, lots, serial numbers)
Lot # 50069132, Expiry date 6/30/2018; Lot # 50083527, Expiry date 11/30/2018; Lot # 50083533, Expiry Date 11/30/2018.
Other devices under the same FDA submission
1 device cleared under K160583 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Refinity ST Rotational IVUS Catheter 89900Philips Image Guided Therapy Corporation · Catheter, Ultrasound, Intravascular29 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 76885).
- Z-1775-2017 · TerminatedRefinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS C…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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