CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter recalled
Volcano is recalling Refinity Rotational Intravascular Ultrasound (IVUS) Catheter. The recall was initiated on 29 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1775-2017
- FDA event ID
- 76885
- Recalling firm
- Volcano, Rancho Cordova, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Mar 2017
- FDA classified
- 13 Apr 2017
- Reported
- 19 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 29 Mar 2017 | Recall initiated by company | |
| 13 Apr 2017 | Classified by FDA | +15 days |
| 19 Apr 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Distribution to US and Japan
Questions about this recall
Why was it 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.
Which lots are affected?
Lot # 50068951, Expiry date 06/30/2018; Lot # 50068952, Expiry date 06/30/2018; Lot # 50069133, Expiry date 06/30/2018; Lot # 50083387, Expiry Date 11/30/2018; Lot # 50083390, Expiry Date 11/30/2018.
Where was it sold?
Distribution to US and Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 76885This product is part of a recall event; the main page for the event is Refinity Short Tip Rotational Intravascular Ultrasound recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Refinity Short Tip Rotational Intravascular Ultrasound recalled | Volcano | Other | CA |
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