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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Abbott Cardiovascular Inflation Devices Recalled for Air Embolism Risk

Agency Publication Date: December 20, 2024
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Summary

Abbott Vascular Inc. is recalling 33,473 cardiovascular inflation devices, including the 20/30 Indeflator and various Priority Pack Accessory Kits. These devices are used during medical procedures to create and monitor pressure in balloon catheters. The recall was initiated because the devices may leak at the hose connection or the pressure gauge, which could accidentally introduce air into a patient's bloodstream. No injuries or incidents have been reported to date, but the devices were distributed to hospitals and surgery centers across 39 U.S. states and multiple international locations.

Risk

A leak in the inflation device could cause an air embolism, which is a bubble of air that enters the blood vessels. This can block blood flow and lead to life-threatening complications, including stroke, heart attack, or permanent organ damage.

What You Should Do

  1. This recall affects the Abbott 20/30 Indeflator (REF 1000184), Priority Pack Accessory Kits (REF 1000186, 1003327), and Priority Pack Kits (REF 1000186-115) with specific lot numbers.
  2. Check the product packaging or device label for the Model/REF number and the lot number to determine if your inventory is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to prevent patient harm.
  4. Contact Abbott Vascular Inc. or your distributor to arrange for the return, replacement, or correction of any affected units.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: 20/30 INDEFLATOR
Model / REF:
1000184
Lot Numbers:
60418466
60418467
60418468
UDI:
08717648013591

Used during cardiovascular procedures in conjunction with interventional devices.

Product: 20/30 Priority Pack Accessory Kit/.096 RHV
Model / REF:
1000186
Lot Numbers:
60538750
60538751
60539113
60545329
UDI:
08717648013614

Used during vascular procedures with interventional and/or diagnostic devices.

Product: 20/30 Priority Pack Accessory Kit w/Copilot
Model / REF:
1003327
Lot Numbers:
60516923
60553232
60553233
60556003
60556008
60556009
60556011
60556012
60556014
60557297
60559370
60559371
60559374
60559375
60559376
60561751
60561752
60561753
60561754
60561755
UDI:
08717648013973

Used for cardiovascular procedures.

Product: 20/30 Priority Pack Kit/.115 RHV
Model / REF:
1000186-115
Lot Numbers:
60564920
60564933
60566431
60566432
60566433
60566667
UDI:
08717648015274

Used for cardiovascular procedures.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95707
Status: Active
Manufacturer: Abbott Vascular Inc
Sold By: Hospitals; Cardiovascular surgery centers
Manufactured In: United States
Units Affected: 4 products (1,418; 3,673; 23,407; 4,975)
Distributed To: Iowa, Maryland, District of Columbia, Indiana, California, Nevada, Texas, Connecticut, Georgia, Mississippi, New York, Ohio, Florida, North Carolina, Michigan, Kentucky, Pennsylvania, Virginia, Illinois, Oklahoma, Tennessee, Utah, Washington, Wisconsin, Montana, Oregon, Louisiana, Hawaii, Nebraska, Arkansas, Missouri, Massachusetts, Kansas, Idaho, Alabama, Arizona, Puerto Rico, Colorado, South Carolina

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.