FDA Medical Device Recalls (openFDA)
Medtronic Vascular: Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
- Recall number
- Z-3253-2018
- Recalling firm
- Medtronic Vascular
- Product
- Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
- Status
- Terminated
- Initiated
- 2018-08-16
- Posted
- not on file
- Terminated
- 2021-05-07
- Reason
- 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
- Error in labeling
- Action
- 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.
- Quantity
- 250 units
- Distribution
- CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
- Lot, serial or model codes
- UDI/GTIN: 20643169738717 Lot Number 60068186
- 510(k) numbers
- ["K161287"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28