The Recall Desk

Hazard

Circulatory Support recalls

8 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
8
Critical
0
Severe
4
Most recent
2026-06-24

Of the 8 circulatory support recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (50%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all circulatory support recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–8 of 8

  • SevereFDA (Devices)·Z-2457-2026·2026-06-24

    Impella CP sets may lose mechanical circulatory support from low purge pressure

    Impella CP Sets with SmartAssist are being recalled because a low purge pressure occurrence may cause persistent alarms and, in some cases, interruption or loss of circulatory support.

    Product
    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2360-2026·2026-06-24

    Automated Impella Controller software error affects left ventricular support devices

    Automated Impella Controllers are being recalled because of a potential software error when used with left ventricular Impella devices. 10,297 units are affected.

    Product
    Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2026·2026-06-24

    HeartMate 11 volt lithium ion backup batteries may fail

    HeartMate 11 Volt Lithium Ion Standalone Backup Batteries, model 106128, are being recalled due to 11 volt backup battery failures. Twelve units are affected.

    Product
    Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2026·2026-06-24

    HeartMate 3 system controllers recalled over backup battery failures

    HeartMate 3 System Controllers, model 106531US, are being recalled due to 11 volt backup battery failures. 694 units are affected.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2518-2026·2026-06-24

    HeartMate 3 assist system kits recalled over backup battery failures

    HeartMate 3 Left Ventricular Assist System kits, model 106524US, are being recalled due to 11 volt backup battery failures. Four units are affected.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1589-2026·2026-04-08

    Impella purge cassettes recalled as Class I over purge leak risk

    Purge Cassettes sold within Impella Pump Sets and individually packaged are being recalled because of an increased risk of purge leaks with Generation 1 purge cassettes.

    Product
    Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge C
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1591-2026·2026-04-08

    Impella controller purge blocked alarm may be delayed on older pumps

    Abiomed is recalling Automated Impella Controllers because the Purge System Blocked alarm display could be delayed when using first generation Impella 5.5 pumps.

    Product
    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Produc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1099-2026·2026-01-21

    Circulatory support blood pumps recalled over locking into the motor

    Thoratec is recalling 8,399 CentriMag blood pump products after reports that the pump may not fit or lock securely into the motor using the screw-in locking feature.

    Product
    CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System
    Category
    Medical Device
    Distribution
    Distributed nationwide