—#166942

Product

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

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K161287
Affected lot / code info: UDI/GTIN: 20643169738717 Lot Number 60068186

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Medtronic Vascular
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

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

Timeline

Recall initiated: 2018-08-16
Terminated: 2021-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166942. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.