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

Recall Z-1058-2016 — Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

U.S. FDA — Device Enforcement · United States · 2016-02-10 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1058-2016
Date of alert: 2016-02-10
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Arrow International, Inc., Division of Teleflex Medical Inc.
Product category: device
Product type: Devices

Reported risk: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

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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