Abbott Vascular inflation device may leak during cardiovascular procedures

Plain-English summary

Abbott Vascular Inc is recalling the 20/30 Priority Pack Accessory Kit (.096 RHV, REF: 1000186), an inflation device used during cardiovascular procedures in conjunction with interventional and diagnostic devices. The device may leak at the hose rotating luer or at the gauge, which could lead to air embolism, a potentially life-threatening condition.

A total of 3,673 units have been distributed across 39 US states, Puerto Rico, and multiple international locations including South Korea, Singapore, Thailand, Vietnam, and several European countries. The affected lot numbers are 60538750, 60538751, 60539113, and 60545329.

Healthcare facilities and providers should identify units by REF number and lot number. If affected devices are in stock, they should be removed from use immediately. Contact Abbott Vascular Inc for return or replacement instructions.

The recalled product

Product

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).

Manufacturer

Abbott Vascular Inc

Category

Medical Device — Cardiovascular / Vascular Intervention

Hazard

• air-embolism
• leak

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls