FDA Medical Device Recalls (openFDA)
Abbott Vascular: NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15
- Recall number
- Z-2038-2017
- Recalling firm
- Abbott Vascular
- Product
- NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15
- Status
- Terminated
- Initiated
- 2017-03-22
- Posted
- 2017-05-12
- Terminated
- 2018-02-07
- Reason
- Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
- Root cause
- Device Design
- Action
- An Urgent Field Safety Notice dated 3/22/17 was sent to customers to inform them that Abbott Vascular is recalling the NC Trek RX Coronary Dilation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PCTA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The letter informs the customers of how does the issue occur and what action is Abbott Vascular asking the customers to take. Customers with any questions are instructed to contact local Abbott Vascular Representative or Customer Service Department at (800) 227-9902. On 5/15/17, Abbott Vascular posted a press release on their website to inform customers that Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.
- Quantity
- 449,661 units total (132,040 units in US)
- Distribution
- US and Worldwide
- Lot, serial or model codes
- Lot Number 61209G1 61209G2 61102G1 61102G1 61012G1 61209G1 61101G1 60415G1 61209G1 61102G1 61101G1 61101G1 61102G1 60415G1 61102G1 61101G1 60415G1 61209G1 61102G1 50415G1 50919G1 51110G1 61209G1 50919G1 51210G1 61101G1 61102G1 60415G1 61102G1 60415G1 61209G1
- 510(k) numbers
- ["K103153"]
- PMA numbers
- not on file
- Product code
- LOX
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- 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