20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
This recall is currently active, issued December 20, 2024. It was issued by Abbott Vascular Inc.
- Company
- Abbott Vascular Inc
- Recall Initiated
- November 6, 2024
- Posted
- December 20, 2024
- Recall Number
- Z-0730-2025
- Quantity
- 1,418
- Firm Location
- Temecula, CA
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
UDI-DI: 08717648013591, Lots: 60418466, 60418467, 60418468
Root Cause
Component change control
Action Taken
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