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Abbott Vascular Inc recalls 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interven
Recalled January 1, 2025 · FDA recall Z-0731-2025 · Abbott Vascular
Hazard
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. · FDA Class II
Units
3,673
Sold at
US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.
Description
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.
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(s)
Abbott Vascular Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →