Boston Scientific Recalls Guidezilla II Catheters Due to Missing Coating
Boston Scientific is recalling Guidezilla II Guide Extension Catheters because they may lack a hydrophilic coating, potentially affecting device performance.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or deaths. The hazard is a manufacturing defect (missing coating) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling specific lots of Guidezilla II Guide Extension Catheters. The recall involves 14,145 devices in 6F and 7F sizes that were sterilized using ethylene oxide. The products were distributed nationwide, including Washington D.C. and Puerto Rico, as well as to Canada.
The recall was initiated because certain catheters may have missed the hydrophilic coating step during the manufacturing process. This coating is intended to create a lubricious surface on the devices. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and consumers should stop using the affected devices and contact Boston Scientific Corporation for further instructions or replacement. Specific lot numbers and expiration dates are listed in the official recall documentation.
The recalled product
- Product
- Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 14,145
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 (4)
- Lot / GTIN Number / Use By: 1. 23485544 / 8714729939450 / 2021-02-10
- 23933296 / 8714729939450 /2021-05-10
- 23947883 / 8714729939450 / 2021-05-12
- 24201181 / 8714729939474 / 2021-06-30.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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