St. Jude Medical Recalls Fast-Cath Transseptal Guiding Introducers Due to Packaging Error
St. Jude Medical is recalling 26 units of Fast-Cath Transseptal Guiding Introducers because they were packaged with a 180-degree curve instead of the labeled 90-degree curve.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging/labeling mismatch regarding the curve style, with no reported injuries or illnesses.
Plain-English summary
St. Jude Medical is recalling a single batch of 26 Fast-Cath Transseptal Guiding Introducers (Model no. 406586, Batch no. 3619533). The devices are indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
The recall was initiated because the devices were packaged as a 180-degree curve style introducer instead of the 90-degree curve style introducer indicated on the labeling. This packaging discrepancy does not match the product description provided to healthcare providers.
The affected units were distributed in the United States, specifically in the states of Florida, Kentucky, and Oklahoma. Healthcare providers should stop using the affected devices and contact St. Jude Medical for further instructions.
The recalled product
- Product
- Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial…
- Manufacturer
- St Jude Medical Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 26
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)
- Model no. 406586 Batch no. 3619533
Distribution
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