Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1134-2020 — NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM 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)

U.S. FDA — Device Enforcement · United States · 2020-01-29 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1134-2020
Date of alert: 2020-01-29
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Abbott Vascular
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 08717648152115

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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