Cordis RadialSource Spring Wire Transradial Access Kit Recalled for Undersized Tip
Cordis and Greatbatch Medical are recalling one lot of RadialSource Spring Wire Transradial Access Kits because some units have an undersized vessel dilator tip that cannot slide over the guidewire.
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 involves a medical device with a functional defect (undersized tip) that prevents proper use. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported, and it does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).
Plain-English summary
Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the Cordis RadialSource Spring Wire Transradial Access Kit. The recall involves 550 kits (OUS) from manufacturing lot W18499722. The product is a medical device used for transradial access procedures.
The recall was initiated because some units were manufactured with an undersized vessel dilator tip. This defect makes the tip too small to slide over the guidewire, which may prevent the device from functioning as intended during the procedure.
The affected products were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, Greece, Hungary, Ireland, Israel, and Italy. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer or distributor for instructions on return or replacement.
The recalled product
- Product
- Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV…
- Manufacturer
- Greatbatch Medical
- Affected units
- 550
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 (1)
- Manufacturing Lot : W18499722
Distribution
Distribution scope not specified by the agency.
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