Z-1775-2017Class II

Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number...

Name: Z-1775-2017 Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number...
Creator: Volcano Corporation
Published: 2017-03-29
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2017-03-29 / Terminated

FDA source

Volcano Corporation began a recall of Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST)... on 2017-03-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1775-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-29
Posted: 2017-04-10
Terminated: 2017-06-21
Recalling firm: Volcano Corporation
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.
Product code: OBJ Catheter, Ultrasound, Intravascular
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 718 total units
Distribution: Distribution to US and Japan
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1775-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1775-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-13
Z-1776-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-13

Product code OBJ

K160583Class IIREFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation / cleared 2016-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)