Z-1143-2020Class I

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX...

Name: Z-1143-2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX...
Creator: Abbott Vascular
Published: 2020-01-29
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2020-01-29 / Terminated

FDA source

Abbott Vascular began a recall of NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for... on 2020-01-29. FDA classified it as Class I and gives the reason as "Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1143-2020
Classification: Class I
Status: Terminated
Initiated: 2020-01-29
Posted: 2020-02-14
Terminated: 2024-04-16
Recalling firm: Abbott Vascular
Product: NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Reason for recall: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
FDA root cause: Process change control
Action: On 01/29/2020, the firm field personnel and Affiliates directly contacted the first customers beyond the firm's control via phone, email, or personal visit to facilitate rapid notification. The "URGENT MEDICAL DEVICE RECALL" Notification informed customers that specific lots of its Coronary Dilatation Catheters with diameters of 4.0 mm, 4.5 mm, and 5.0 mm may exhibit difficulty or inability to deflate the balloon due to weaker material proximal to the balloon bond resulting from excess heat exposure during manufacturing, and the potential risks with the use of the affected products include air embolism, thrombosis, myocardial infarction and additional intervention. Healthcare Professionals will be instructed to: " Reference the attached list of affected part numbers and lot numbers " Immediately stop using affected devices from these lots " Review your inventory, complete and return the attached Effectiveness Check Form " Return all unused affected product to Abbott " Share this notification with other relevant personnel in their organization The action the Recalling Firm is taking: * Stopped shipping affected lots * Will implement appropriate corrective actions to ensure product performance * Field Representatives can assist in identifying and returning affected devices * Will work with customers to replace returned units with similar devices, pending availability. For any questions, contact Customer Service Department at (800) 227-9902.
Quantity in commerce: Total 791 Traveler (0 US and 791 OUS)
Distribution: Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam
Product codes and lots: Device Identifier/GTIN: 08717648196027 Part Number: 1013158-08 Lot Numbers:90812G1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1143-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1128-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1129-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1130-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1131-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1132-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1133-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1134-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1135-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1136-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1137-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1138-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1139-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1140-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1141-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1142-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1143-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1144-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14

Product code LOX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)