The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1775-2017·Announced 2017-04-19

Volcano Recalls Refinity Rotational Intravascular Ultrasound Catheters Due to Kinking

Volcano Corporation is recalling 718 Refinity Rotational Intravascular Ultrasound Catheters because high complaint rates indicate kinking near the proximal shaft, which could 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no injuries or illnesses have been reported, and the hazard is limited to workflow disruption or loss of imaging rather than direct physical harm.

Plain-English summary

Volcano Corporation is recalling 718 units of the Refinity Rotational Intravascular Ultrasound (IVUS) Catheter, product number 400-0200.289, catalog number 89800. The affected lots are 50068951, 50068952, 50069133, 50083387, and 50083390, with expiry dates ranging from June 30, 2018, to November 30, 2018. The devices were distributed to the United States and Japan.

The recall was initiated 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 Refinity catheter is intended for intravascular ultrasound examination of coronary arteries in patients who are candidates for transluminal interventional procedures.

Healthcare providers and facilities that have received these specific lots should stop using the affected catheters and contact Volcano Corporation for further instructions on return or replacement. No injuries or illnesses have been reported in the source text.

The recalled product

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…
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 (8)

  • Lot # 50068951
  • Expiry date 06/30/2018
  • Lot # 50068952
  • Lot # 50069133
  • Lot # 50083387
  • Expiry Date 11/30/2018
  • Lot # 50083390
  • 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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