Volcano Visions IVUS catheters can entangle with the guide wire
Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.
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 3/5 (High).
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: Risk-of-harm product: catheter and guide wire entanglement that the notice says may require surgical removal, with no injury count stated in the source.
Plain-English summary
The Volcano Visions Digital IVUS Catheter, covering PV.014P (Platinum) REF 85910P, PV.014P RX REF 014R, and PV.018 REF 86700 and 86700J, used with its instructions for use, is being recalled. The action covers 233,817 units, UDI-DI 00845225002848 and 00184360000037.
The stated reason is reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without an appropriate sheath and/or guide catheter, which may require further intervention such as surgical removal. The firm is restating its instructions for use and adding guidance to use a guide sheath of appropriate length. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States.
Facilities should identify affected stock using the REF and UDI-DI codes above and follow the revised instructions for use issued by the manufacturer.
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
- Affected units
- 233,817
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
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