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U.S. Department of Health and Human Services

Class 2 Device Recall INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK

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 Class 2 Device Recall INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACKsee related information
Date Initiated by FirmNovember 06, 2024
Date PostedDecember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0732-2025
Recall Event ID 95707
510(K)NumberK961471 
Product Classification Syringe, balloon inflation - Product Code MAV
Product20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Code Information UDI-DI: 08717648013973, Lots: 60516923, 60553232, 60553233, 60556003, 60556008, 60556009, 60556011, 60556012, 60556014, 60557297, 60559370, 60559371, 60559374, 60559375, 60559376, 60561751, 60561752, 60561753, 60561754, 60561755
FEI Number 2024168
Recalling Firm/
Manufacturer		 Abbott Vascular Inc
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information ContactAlicia Swanson
408-845-3427
Manufacturer Reason
for Recall		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 Determined
Cause 2		Component change control
ActionOn 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
Quantity in Commerce23,407
DistributionUS: 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MAV
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