Abbott 20/30 Priority Pack Kit (Abbott) – Inflation Device Leak (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Abbott Vascular Inc
Lot Codes / Batch Numbers
UDI-DI: 08717648013614, Lots: 60538750, 60538751, 60539113, 60545329
Products Sold
UDI-DI: 08717648013614, Lots: 60538750, 60538751, 60539113, 60545329
Abbott Vascular Inc is recalling 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conju due to 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 e. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MS, MO, MT, NE, NV, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, DC, PR
Page updated: Jan 10, 2026