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

Recall Z-2038-2017 — NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15

U.S. FDA — Device Enforcement · United States · 2017-03-22 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2038-2017
Date of alert: 2017-03-22
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Abbott Vascular
Product category: device
Product type: Devices

Reported risk: Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating 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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