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

Recall Z-0731-2025 — 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

U.S. FDA — Device Enforcement · United States · 2024-11-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0731-2025
Date of alert: 2024-11-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Vascular Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 08717648013614

Reported risk: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

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.

Recall Z-0731-2025 — 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

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