Volcano Visions IVUS Catheter Recall Due to Guide Wire Entanglement Risk
Volcano Corp recalls approximately 233,817 IVUS catheters that may become entangled with guide wires during radial-to-peripheral procedures when used without appropriate guide sheaths. Entanglement may require surgical removal.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving risk of serious harm requiring potential surgical intervention due to device entanglement. The source reports incidents of entanglement but does not explicitly document hospitalizations or actual injuries, placing this at High severity under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Volcano Corp is recalling approximately 233,817 units of the Volcano Visions Digital IVUS Catheter, including models PV.014P (Platinum), PV.014P RX, and PV.018. These catheters are used in interventional cardiology procedures to visualize blood vessels during vascular interventions.
The FDA has received reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures when the catheter is used without appropriate guide sheath and/or guide catheter support. Entanglement may require further medical intervention, including surgical removal of the device.
The affected devices have been distributed worldwide, including throughout the United States and to countries including Brazil, Poland, Slovakia, Italy, Germany, the United Kingdom, Denmark, Austria, Kuwait, Costa Rica, Spain, Netherlands, Latvia, Malta, Ireland, Switzerland, South Africa, Romania, Finland, Puerto Rico, France, Canada, Panama, El Salvador, Sweden, Portugal, Croatia, Greece, New Zealand, Hong Kong, Taiwan, Malaysia, Thailand, Mexico, Argentina, Peru, United Arab Emirates, Bulgaria, Australia, Japan, Indonesia, and Serbia.
Volcano Corp is restating the device's instructions for use and adding a specific requirement to use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guide wire.
The recalled product
- Product
- Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
- Manufacturer
- Volcano Corp
- Hazard
- entanglement
- device-retrieval-risk
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 (3)
- UDI-DI: 00845225002848
- 00184360000037. Instructions for use: 300004875732_A Revision Date: 03/2021
- 300004410212.A Release Date: 03/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03