Inflation Device for Cardiovascular Procedures Risk of Air Embolism from Potential Leak
Abbott Vascular inflation devices used in heart procedures may leak at connection points, potentially causing air embolism in patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries to date. The hazard—air embolism from device leak—represents significant risk of serious harm, meeting the rubric criterion for risk-of-harm products without reported injuries.
Plain-English summary
Abbott Vascular Inc is recalling the 20/30 Priority Pack Kit/.115 RHV (REF: 1000186-115), an inflation device used during cardiovascular procedures. Approximately 4,975 units have been affected by this recall.
The device may leak at the indeflator, specifically at the hose rotating luer or at the gauge. This leak could allow air to enter a patient's bloodstream during a procedure, potentially causing air embolism, a serious and potentially life-threatening condition.
The affected devices were distributed across 36 U.S. states, the District of Columbia, Puerto Rico, and 20 international countries. The specific lot numbers involved in this recall are: 60564920, 60564933, 60566431, 60566432, 60566433, and 60566667. Patients and healthcare providers should verify whether procedures used these specific lot numbers.
The recalled product
- Product
- 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
- Manufacturer
- Abbott Vascular Inc
- Hazard
- air-embolism
- device-leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI: 08717648015274
- Lots: 60564920
- 60564933
- 60566431
- 60566432
- 60566433
- 60566667
Distribution
Distributed in 40 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MO
- MS
- MT
- NC
- NE
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- SC
- TN
- TX
- UT
- VA
- WA
- WI
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