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Abbott Vascular Inc

Abbott Vascular Inc Recalls

All product recalls associated with Abbott Vascular Inc.

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Recall Summary

Total Recalls

154

Past Year

19

Class I (Serious)

41

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 154 recalls

Abbott 20/30 Priority Pack Kit (Abbott) – Inflation Device Leak (2024)

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

FDANov 6, 2024AL, AZ, AR +37 more• Abbott Vascular Inc

Abbott 20/30 Indeflator (Abbott) – Inflation Device Leak (2024)

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

FDANov 6, 2024AL, AZ, AR +37 more• Abbott Vascular Inc

Abbott 20/30 Priority Pack Kit (Abbott) – Inflation Device Leak (2024)

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

FDANov 6, 2024AL, AZ, AR +37 more

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• Abbott Vascular Inc

Abbott Navitor Heart Valve (Abbott) – Manufacturing Specification (2024)

A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

FDAOct 17, 2024NY• Abbott Medical

Abbott Navitor Titan Valve (Abbott) – Manufacturing Specification (2024)

A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

FDAOct 17, 2024NY• Abbott Medical

Abbott Navitor Heart Valve (Abbott) – Manufacturing Specification (2024)

A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

FDAOct 17, 2024NY• Abbott Medical

Abbott Navitor Heart Valve (Abbott) – Manufacturing Specification (2024)

A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

FDAOct 17, 2024NY• Abbott Medical

Merlin@home Transmitter (Abbott) – Software Upgrade Failure (2024)

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

FDAOct 1, 2024Nationwide• Abbott Medical

Merlin@home Transmitter with MerlinOnDemand (Abbott) – Software Upgrade Failure (2024)

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

FDAOct 1, 2024Nationwide• Abbott Medical

Abbott Molecular, Inc.: Abbott Alinity m STI AMP Kit, used with the Alinity m Sys...

Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

FDASep 12, 2024Nationwide• Abbott Molecular, Inc.

Abbott Molecular, Inc.: Abbott Alinity m HPV AMP Kit, used with the Alinity m Sys...

Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

FDASep 12, 2024Nationwide• Abbott Molecular, Inc.

Abbott Diabetes Care, Inc.: FreeStyle Libre 3 Sensors, REF: 72081-01, component of th...

Laceration Risk

Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.

FDAJul 24, 2024CA, FL, MN +9 more• Abbott Diabetes Care, Inc.

Abbott Diagnostics Technologies AS Kjelsasveien: Afinion 2 Analyzer, model #1116986, US refurbished, CLIA ...

Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.

FDAJun 17, 2024Nationwide• Abbott Diagnostics Technologies AS Kjelsasveien

Abbott Laboratories: Alinity hq Analyzer, REF: 09P68-01

1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts

FDAJun 14, 2024Nationwide• Abbott Laboratories

Abbott Medical: Abbott Infinity 7, Implantable Pulse Generator, REF: 6662...

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

FDAMay 22, 2024Nationwide• Abbott Medical

Abbott Medical: Abbott Infinity 5, Implantable Pulse Generator, REF: 6660...

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

FDAMay 22, 2024Nationwide• Abbott Medical

Abbott Medical: Abbott Proclaim XR 5 Implantable Pulse Generator, REF 366...

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

FDAMay 16, 2024Nationwide• Abbott Medical

Abbott Medical: Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3...

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

FDAMay 16, 2024Nationwide• Abbott Medical

Abbott Medical: Abbott Proclaim XR 7 Implantable Pulse Generator, REF 36...

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

FDAMay 16, 2024Nationwide• Abbott Medical

Abbott Medical: Proclaim 5 Elite Implantable Pulse Generator, REF 3660, S...

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

FDAMay 16, 2024Nationwide• Abbott Medical