Cardiovascular Systems Recalls ViperWire Advance Guide Wires Due to Packaging Error
Cardiovascular Systems Inc is recalling 595 units of ViperWire Advance guide wires because 0.018-inch products were packaged as 0.014-inch.
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, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard involves a packaging error that could lead to the use of an incorrect device size during a procedure, representing a risk of harm without reported fatalities or Class I classification.
Plain-English summary
Cardiovascular Systems Inc is recalling 595 units of the ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire. The recall affects three specific lots: 175069, 175070, and 176255. The product is a medical device used in percutaneous orbital atherectomy systems for treating occlusive atherosclerotic disease in peripheral arteries and hemodialysis grafts.
The recall was initiated because it was discovered that 0.018-inch ViperWire Advance with Flextip products were incorrectly packaged and labeled as 0.014-inch ViperWire Advance with Flextip products. This packaging error could lead to the use of the wrong size guide wire during a medical procedure.
The affected products were distributed nationwide in the United States, specifically in the states of AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, and WA. Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the product if it matches the description.
The recalled product
- Product
- ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems…
- Manufacturer
- Cardiovascular Systems Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 595
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)
- Lot #: 175069
- 175070
- 176255
Distribution
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