Medtronic Diagnostic Catheter Recalled for Incorrect French Size Labeling
Medtronic is recalling 250 units of DxTerity TRA 5F Diagnostic Catheters because the inner pouch may incorrectly display a 6 French size indicator instead of the correct 5 French size.
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 minor labeling error on the inner pouch where the catheters themselves are the correct item.
Plain-English summary
Medtronic Vascular is recalling 250 units of the DxTerity(TM) TRA 5F Diagnostic Catheter, reference number U5TRAN35. The recall was initiated because the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size.
The source text confirms that the catheters inside the pouch are the correct U5TRAN35 item. Additionally, the outer carton contains all correct labeling, and all other information and configuration details on both the carton and the pouch are accurate. The affected units are identified by UDI/GTIN 20643169738717 and Lot Number 60068186.
The affected units were distributed in California, Iowa, Nebraska, Tennessee, Texas, Virginia, Washington, Jamaica, New Zealand, and Thailand. Healthcare providers and consumers should verify the lot number and UDI/GTIN of their inventory against the recall details. If the product matches the recalled lot, it should be removed from use and returned to Medtronic Vascular or the distributor.
The recalled product
- Product
- Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
- Manufacturer
- Medtronic Vascular
- Hazard
- Affected units
- 250
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)
- UDI/GTIN: 20643169738717 Lot Number 60068186
Distribution
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