Medtronic recalls specific DxTerity Diagnostic Catheters due to potential incorrect size labeling on the box, which could lead to improper use. Affected units have a 6F color code on the box but are labeled 5F inside.
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
Take action
Contact the company
📍Recalling firmMedtronic Vascular35-37A Cherry Hill Drive · Danvers, MA 01923-2565
“Medtronic DxTerity Diagnostic Catheter Recall: Incorrect Size Labeling Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71722-medtronic-dxterity-diagnostic-catheter-recall-incorrect-size-labeling-risk. Based on FDA recall #Z-1479-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1479-2018%22&limit=1).
The FDA announced on March 13, 2018, that Medtronic Vascular is recalling the DxTerity Diagnostic Catheter because the outer box may incorrectly display a 6 French color code instead of the correct 5 French size. GovInfoNow's records show this voluntary Class II recall affects 855 units distributed in the U.S., Austria, Canada, Germany, Romania, and Slovenia.
How to tell if you have it
Brand: Medtronic Vascular
Product: DxTerity Diagnostic Catheter, JL 4.0
REF: DXT5JL40
Box marking: 6F color code
UDI: 20643169689309
Lot Number: 60074805
The hazard
The hazard is that the color coded French size indicator on the outer box may incorrectly reflect a 6 French size rather than the correct 5 French size. The catheters inside are the correct item with proper inner pouch labeling, but the external packaging error poses a potential identification risk.
Context
GovInfoNow's records show Medtronic Vascular has 5 other recalls on record since August 16, 2018. Other recent recalls of similar products include Medline Medical Procedure Kits: Catheter Issues Recalled (May 4, 2026) and Medline Intubation Tray Recall: Risk of Airway Obstruction from Wrong Suction Catheter (December 24, 2025).
How to tell if you have this one
Check the box for a 6F color code. The catheter is labeled DXT5JL40 with 5F inside the pouch. The UDI is 20643169689309 and lot number 60074805.
Brand
Medtronic Vascular
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Box Labeling
Look for a 6F color code on the outer box of the catheter.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1479-2018 (March 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1479-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.