Abbott Vascular Inflation Device May Leak During Cardiovascular Procedures
Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing 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 risk-of-harm product where the potential hazard (air embolism during cardiovascular procedures) could cause serious injury or death. However, no illnesses or injuries are reported in the source text. The FDA Class II classification without documented hospitalization reports, combined with the theoretical nature of the hazard, places this at the High severity level.
Plain-English summary
The 20/30 Priority Pack Accessory Kit w/Copilot (REF: 1003327) is an inflation device used during cardiovascular procedures. Abbott Vascular Inc is recalling approximately 23,407 units distributed across the United States, U.S. territories, and international markets.
The device may leak at the hose rotating luer or at the gauge. This leak could allow air to enter the cardiovascular system during a procedure, potentially causing air embolism, a serious medical condition that can occur during cardiovascular interventions.
Healthcare facilities and cardiovascular centers with affected devices should immediately identify and quarantine units matching the specified lot numbers. Contact Abbott Vascular for replacement or further guidance. Do not use affected units in patient procedures until the issue is resolved.
The recalled product
- Product
- 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, 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 (20)
- UDI-DI: 08717648013973
- Lots: 60516923
- 60553232
- 60553233
- 60556003
- 60556008
- 60556009
- 60556011
- 60556012
- 60556014
- 60557297
- 60559370
- 60559371
- 60559374
- 60559375
- 60559376
- 60561751
- 60561752
- 60561753
- 60561754
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
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27