Volcano Pioneer Plus Re-Entry Catheter Recalled for Manufacturing Defect
Volcano Corporation is recalling 5,042 Pioneer Plus Re-Entry Catheters due to a manufacturing defect that may allow a small wire to extend through the catheter shaft.
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: The recall is classified as FDA Class II. The hazard involves a potential mechanical failure (wire extension) in a medical device used in the vasculature, which poses a risk of harm, but the source text does not report specific injuries or hospitalizations.
Plain-English summary
Volcano Corporation is recalling 5,042 units of the Pioneer Plus Re-Entry Catheter (Product Code PPLUS20) due to a manufacturing defect. The defect creates a possibility that a small wire could extend through the catheter shaft of the device.
The affected devices are intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The recall includes all lots of the product. Distribution was worldwide, including the United States, Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
Healthcare providers and patients should contact Volcano Corporation for further information regarding the recall and potential replacement or repair options.
The recalled product
- Product
- Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters…
- Manufacturer
- Volcano Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 5,042
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 (2)
- Product Code PPLUS20
- All lots
Distribution
Distributed nationwide across the United States.
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