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).
Recall
- Recall Number
- Z-0731-2025
- Event Number
- 95707
- Firm
- Abbott Vascular Inc
- FEI Number
- 2024168
- Product Code
- MAV
- Status
- Open, Classified
- Root Cause
- Component change control
- Initiated
- November 6, 2024
- Posted
- December 20, 2024
- Address
- 26531 Ynez Rd, Temecula, CA, 92591-4630
Description
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).
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.
On 11/6/2024, recall notices were distributed to customers asking them to take the following actions: 1) Stop using affected devices. 2) Complete and return the acknowledgement form. 3) Return unused devices to the firm. 4) Share this notification with relevant personnel in your organization. 5) If you have further distributed/transferred the affected products, notify those customers. If you have any questions contact firm customer service at 800-227-9902
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