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Recall Observatory FDA recall evidence

Device product

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.

Z-0730-2025

November 06, 2024

Class II

Product summary

Firm
Abbott Vascular Inc
Event
Event 95707
Status
Ongoing
Classification
Class II
Quantity
1,418
Official record key
device-enforcement:Z-0730-2025

Official wording

Reason: 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.

Code information: UDI-DI: 08717648013591, Lots: 60418466, 60418467, 60418468

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.