Boston Scientific Recalls RunWay Guide Catheters Due to Sterility Concerns
Boston Scientific is recalling seven RunWay Guide Catheters because their sterile pouches may not be completely sealed, potentially compromising sterility.
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 potential sterility breach, posing a risk of bacteremia. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling seven units of the RunWay Guide Catheter, Catalog Number 38969-664. The recall was initiated because the sterile pouches for these devices may not be completely sealed, which could compromise the sterility of the catheters.
The devices were distributed to locations in Texas and Russia. The most common adverse health consequence expected from using a device with an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
Healthcare providers and consumers should check their inventory for this specific catalog number and lot code (2013040058). If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority.
The recalled product
- Product
- Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Affected units
- 7
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)
- 2013040058
Distribution
Distribution scope not specified by the agency.
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