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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,418
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
Part of a larger recall action
This product is one of 4 recalled by Abbott Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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