# FDA recall Z-1129-2020

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

## Product

NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC     The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

## 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-1129-2020
- **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-1129-2020

## Citation

> AI Analytics. FDA recall Z-1129-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1129-2020. Source: US FDA. Licensed CC0.

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