Abbott Vascular inflation device may leak during cardiovascular procedures
Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.
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: FDA Class II device recall for a risk-of-harm product (potential air embolism during cardiovascular procedures) with no reported hospitalizations or injuries documented in the source. The hazard is serious but remains theoretical.
Plain-English summary
Abbott Vascular Inc is recalling the 20/30 Priority Pack Accessory Kit (.096 RHV, REF: 1000186), an inflation device used during cardiovascular procedures in conjunction with interventional and diagnostic devices. The device may leak at the hose rotating luer or at the gauge, which could lead to air embolism, a potentially life-threatening condition.
A total of 3,673 units have been distributed across 39 US states, Puerto Rico, and multiple international locations including South Korea, Singapore, Thailand, Vietnam, and several European countries. The affected lot numbers are 60538750, 60538751, 60539113, and 60545329.
Healthcare facilities and providers should identify units by REF number and lot number. If affected devices are in stock, they should be removed from use immediately. Contact Abbott Vascular Inc for return or replacement instructions.
The recalled product
- Product
- 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
- Manufacturer
- Abbott Vascular Inc
- Hazard
- Affected units
- 3,673
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 (5)
- UDI-DI: 08717648013614
- Lots: 60538750
- 60538751
- 60539113
- 60545329
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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