DxTerity TRA recallZ-3253-2018 · Medtronic Vascular · initiated Aug 16, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Vascular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
FDA root cause category: Error in labeling
What the company is doing
Medtronic initiated consignee communications on 16-Aug-2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.
Recall details
- Recall number
- Z-3253-2018
- Status
- Terminated
- Initiated by the company
- Aug 16, 2018
- Recalling firm
- Medtronic Vascular
- Quantity
- 250 units
- Product code
- DQO
- FDA submissions
- K161287
- Distribution
- CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
Product description
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Code information (models, lots, serial numbers)
UDI/GTIN: 20643169738717 Lot Number 60068186
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DxTerity™ TRA U5TRAN35Medtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
Product lines
Other devices under the same FDA submission
14 devices cleared under K161287 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DxTerity™ DXT5JL40Medtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- DxTerity™ DXT5JL35Medtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- DxTerity™ TRA U5ULTRA40SHMedtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- DxTerity™ DXT6JL40Medtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DxTerity™ DXT5JR40Medtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DxTerity™ DXT5PIGSTAMedtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DxTerity™ TRA U5TRAP35SHMedtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DxTerity™ TRA U5TRAP40SHMedtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DxTerity™ TRA U6TRAP40SHMedtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DxTerity™ TRA U5TRAN35SHAMedtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DxTerity™ TRA U5TRAN45SHAMedtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- DxTerity™ TRA U5TRACTSHAMedtronic, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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