St. Jude Medical Recalls Fast-Cath Trio Hemostasis Introducer Due to Dilator Defect
St. Jude Medical is voluntarily recalling 220 units of the Fast-Cath Trio Hemostasis Introducer because the dilator is too small to allow guidewire advancement, potentially causing procedural delays.
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 explicitly states the hazard results in procedural delay rather than injury or illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
St. Jude Medical is conducting a voluntary recall of 220 units of the 10F Fast-Cath Trio Hemostasis Introducer, Catalog number 406308, Batch # 4641580. The product is a sterile medical device consisting of a port hemostasis adapter, sheath, dilator, and guidewire.
The recall is due to a manufacturing defect where the inner diameter of the 10F dilator is too small. This prevents the guidewire from advancing through the device, which may result in a procedural delay while a replacement dilator is obtained. The agency classifies this as a Class II recall.
The affected units were distributed nationwide, including in Florida, Indiana, Maine, Massachusetts, New York, Ohio, Rhode Island, Texas, and West Virginia. Healthcare facilities should stop using the affected lots and contact St. Jude Medical for instructions on returning the product.
The recalled product
- Product
- St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product…
- Manufacturer
- St Jude Medical
- Category
- Medical Device — Cardiovascular
- Affected units
- 220
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)
- Batch 4641580
Distribution
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