The Recall Desk

Hazard

Pulmonary Embolism 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
6
Most recent
2024-08-28

Of the 8 pulmonary embolism recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (75%) 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 pulmonary embolism 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-2587-2024·2024-08-28

    ClotTriever XL Catheter instructions updated to prevent device entrapment and embolism

    Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.

    Product
    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2023·2023-08-02

    Argon Medical Option Elite Vena Cava Filter Recall Due to Performance Risk

    Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.

    Product
    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2022·2022-07-20

    Pressure Monitoring Sets with Excess Coating Pose Embolism Risk

    Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.

    Product
    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1771-2020·2020-04-29

    Acutus Medical Recalls AcQGuide Flex Steerable Introducer Due to Foreign Material

    Acutus Medical Inc is recalling 5 units of the AcQGuide Flex Steerable Introducer because manufacturing defects may have left foreign material particulates on the device.

    Product
    Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1770-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Flextra Steerable Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 30 units of Rhythm Xience Flextra Steerable Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1769-2020·2020-04-29

    Acutus Medical AcQGuide Introducer Recalled for Foreign Material Particulates

    Acutus Medical Inc is recalling 268 units of AcQGuide Mini Fixed-Curve Introducers because manufacturing defects may have left foreign material on the devices.

    Product
    Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1768-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Guider Catheter Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 108 units of Rhythm Xience Guider Catheter Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2209-2015·2015-08-05

    Skeletal Kinetics Recalls InjectionPlasty 1.0 Bone Void Filler Kits

    Skeletal Kinetics is recalling 67 kits of InjectionPlasty 1.0 Bone Void Filler due to reports of venous uptake, DVT, and pulmonary embolism in implanted patients.

    Product
    InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty
    Category
    Medical Device
    Distribution
    1 state