Abbott 20/30 Indeflator devices recalled for potential leak risk
Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.
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: This is a Class II recall of a cardiovascular medical device with a theoretical risk of serious harm (air embolism) from a potential leak defect. No illnesses or injuries have been reported, meeting the criterion for a High-severity recall: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Abbott Vascular Inc is recalling 1,418 units of the 20/30 Indeflator (Reference 1000184), a medical device used during cardiovascular procedures to create and monitor balloon pressure in conjunction with interventional devices such as balloon dilatation catheters.
The recalled device may leak at the hose rotating luer connection or at the gauge. If leakage occurs during use, air could enter the patient's bloodstream, potentially causing air embolism, a serious medical condition.
The affected product was distributed to healthcare facilities across the United States and internationally. Healthcare providers should identify units with affected lot numbers (60418466, 60418467, 60418468) and contact Abbott Vascular for replacement or return instructions. No illnesses or injuries have been reported to date.
The recalled product
- 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.
- Manufacturer
- Abbott Vascular Inc
- Hazard
- air-embolism
- 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 (4)
- UDI-DI: 08717648013591
- Lots: 60418466
- 60418467
- 60418468
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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