Abbott NC Traveler Coronary Dilatation Catheter Recalled for Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it indicates a reasonable probability of serious adverse health consequences.
Plain-English summary
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters (REF 1013158-12, Lot 90813G1) due to a potential defect where the balloon may exhibit difficulty or inability to deflate. The recall involves a total of 791 units, all of which were distributed outside the United States. The source text explicitly states that the NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. The specific hazard identified is the mechanical failure of the balloon to deflate, which could compromise the intended function of the coronary dilatation procedure.
Healthcare providers and facilities that may have received these devices should stop using them and contact Abbott Vascular for further instructions. Since the product is not cleared for commercial distribution in the US, US consumers are not expected to have access to this specific lot through standard commercial channels.
The recalled product
- Product
- NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by Abbott Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
Same manufacturer · Abbott Vascular
See all →- HighMitraClip Clip Delivery System Recalled for Locking Malfunctions
FDA (Devices) · 2022-10-26
- HighAbbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk
FDA (Devices) · 2022-10-26
- HighMitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction
FDA (Devices) · 2022-10-26
- SevereDragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk
FDA (Devices) · 2022-05-25
- HighAbbott Vascular Cardiovascular Device Recalled for Leaks and Loose Connections
FDA (Devices) · 2022-04-20
Same hazard · mechanical failure
See all →- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- CriticalAbbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues
FDA (Devices) · 2017-05-24
- SevereAbbott NC Trek RX Coronary Dilatation Catheter Recall for Sheath Removal Issues
FDA (Devices) · 2017-05-24
- SevereAbbott NC Tenku RX Balloon Catheter Recall for Sheath Removal Issues
FDA (Devices) · 2017-05-24
- HighCordis EMPIRA NC RX PTCA Dilatation Catheter Recalled for Balloon Defect
FDA (Devices) · 2014-09-03
- ModerateMedtronic NC Sprinter Balloon Catheter Recalled for Incorrect Size Labeling
FDA (Devices) · 2013-10-09
- HighCordis EMPIRA RX PTCA Dilatation Catheter Recalled for Balloon Cover Removal Issues
FDA (Devices) · 2014-09-03