Reported Jan 1, 2025 · Ongoing
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices…
Abbott Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular Inc · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
- 20/30 INDEFLATOR
- REF1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon
- Lot codes and dates
- UDI-DI08717648013591
- Lots
604184666041846760418468
- Amount recalled
- 1,418
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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