The Recall Desk

Hazard

Thrombus Formation recalls

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

What the numbers show

Total
5
Critical
0
Severe
3
Most recent
2026-07-08

Of the 5 thrombus formation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (60%) 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 thrombus formation 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.

1–5 of 5

  • SevereFDA (Devices)·Z-2615-2026·2026-07-08

    Reprocessed Electrophysiology Catheters Recalled for Residual Particles

    Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.

    Product
    Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2602-2026·2026-07-01

    Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kit Recall

    Abiomed is recalling Impella CP Set with SmartAssist (10th Generation) containing 14Fr Low Profile Introducer Kits due to potential thrombus (blood clot) formation during prolonged use of the introducer.

    Product
    Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2600-2026·2026-07-01

    Abiomed Impella CP Introducer Kit Recalled for Thrombus Risk

    Abiomed is recalling the 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP due to potential thrombus formation during prolonged use. The recall affects 17 units distributed in the United States and Japan.

    Product
    Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2143-2020·2020-06-03

    Spectranetics Bridge Occlusion Balloon Recalled for Thrombus Formation Risk

    Spectranetics is recalling Bridge Occlusion Balloons because current labeling is insufficient to warn users about the risk of thrombus formation if the device remains in the vasculature for long durations.

    Product
    Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2020·2020-03-04

    Cook Inc. Recalls Zenith Alpha Spiral-Z Endovascular Leg Grafts

    Cook Inc. is recalling Zenith Alpha Spiral-Z Endovascular Leg grafts due to identified factors contributing to thrombus formation and lumen occlusion. The product is distributed only outside the United States.

    Product
    Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
    Category
    Medical Device
    Distribution
    0 states