Medtronic Vascular: Medical Device Recall in 2018 - (Recall #: Z-3253-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

Product Classification:

Class III

Date Initiated: August 16, 2018

Date Posted: October 3, 2018

Recall Number: Z-3253-2018

Event ID: 80919

Reason for Recall:

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.

Status: Terminated

Product Quantity: 250 units

Code Information:

UDI/GTIN: 20643169738717 Lot Number 60068186

Distribution Pattern:

CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand

Voluntary or Mandated:

Voluntary: Firm initiated