Medtronic DxTerity Diagnostic Catheter Recalled for Incorrect Box Labeling
Medtronic is recalling 855 units of DxTerity Diagnostic Catheters because the outer box displays an incorrect 6 French size indicator, though the catheters inside are correct.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a packaging-only labeling error where the actual medical device inside is correct and properly labeled, fitting the criteria for cosmetic or documentation issues.
Plain-English summary
Medtronic Vascular is recalling 855 units of the Medtronic DxTerity Diagnostic Catheter, model JL 4.0, reference DXT5JL40. The recall is due to a labeling error on the outer packaging box, which may incorrectly display a 6 French size indicator instead of the correct 5 French size.
The catheters inside the carton are the correct DXT5JL40 items, and the inner pouch contains the correct 5F labeling, information, and configuration details. The affected units are identified by UDI 20643169689309 and Lot Number 60074805.
These products were distributed in the US, Austria, Canada, Germany, Romania, and Slovenia. Healthcare providers should verify the inner pouch labeling to ensure the correct 5 French size is used for procedures, as the outer box indicator is inaccurate.
The recalled product
- Product
- Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
- Manufacturer
- Medtronic Vascular
- Hazard
- Affected units
- 855
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 (2)
- UDI 20643169689309
- Lot Number 60074805
Distribution
Distribution scope not specified by the agency.
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