The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1776-2017·Announced 2017-04-19

Volcano Recalls Refinity Short Tip Rotational IVUS Catheters Due to Kinking

Volcano Corporation is recalling 718 Refinity Short Tip Rotational IVUS Catheters due to high complaint rates of kinking near the proximal shaft junction, which may disrupt clinical workflow or cause loss of imaging.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with significant operational failures like loss of imaging in a medical device.

Plain-English summary

Volcano Corporation is recalling 718 units of the Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter, product number 400-0200.273, catalog number 89900. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is being issued due to high complaint rates of kinking near the junction of the proximal shaft to the telescope section of the catheter. This defect could result in the disruption of normal clinical workflow or the loss of imaging during procedures.

The affected devices were distributed to the United States and Japan. The specific lots involved are #50069132 (expiry 6/30/2018), #50083527 (expiry 11/30/2018), and #50083533 (expiry 11/30/2018). Healthcare providers should stop using these devices and contact Volcano Corporation for further instructions.

The recalled product

Product
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…
Manufacturer
Volcano Corporation
Category
Medical Device — Cardiovascular
Hazard
Affected units
718

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot # 50069132
  • Expiry date 6/30/2018
  • Lot # 50083527
  • Expiry date 11/30/2018
  • Lot # 50083533
  • Expiry Date 11/30/2018.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Volcano Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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