# FDA recall Z-1142-2020

> **Abbott Vascular** · Class I · device recall initiated 2020-01-29.

## Product

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM     The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

## Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

## 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                          

## Key facts

- **Recall number:** Z-1142-2020
- **Recalling firm:** Abbott Vascular
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-29
- **Report date:** 2020-02-26
- **Termination date:** 2024-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Temecula, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1142-2020

## Citation

> AI Analytics. FDA recall Z-1142-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1142-2020. Source: US FDA. Licensed CC0.

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