Skip to content
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.

Field note

Send feedback

We'll only use this to respond to your feedback.