The Recall Desk

Hazard

Embolization recalls

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

What the numbers show

Total
69
Critical
10
Severe
47
Most recent
2024-05-15

Of the 69 embolization recalls we have scored against our rubric, 10 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 47 (68%) 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 embolization 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.

26–50 of 69

  • SevereFDA (Devices)·Z-0231-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Inner Lumen Detachment Recall

    The inner lumen of Arrow-Trerotola Over-The-Wire PTD catheters (7FR) can detach from the device, causing an embolism. This requires additional medical intervention and delays treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0234-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk

    Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0232-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Catheter Lumen Detachment Recall

    Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-veno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0233-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device inner lumen detachment and embolization risk

    Arrow-Trerotola PTD catheters are being recalled because the inner lumen can detach from the device basket, causing embolization that requires additional intervention. 1,167 units are affected.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0599-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0604-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0610-2021·2020-12-30

    Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk

    Cook Inc. is recalling 902 Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0607-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0608-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0596-2021·2020-12-30

    Flexor Check-Flo Introducer sheath separation recall due to potential life-threatening complications

    The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0605-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0598-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0606-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0592-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling 383 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0603-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0600-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0591-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0601-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0609-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

    Cook Inc. is recalling 631 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0611-2021·2020-12-30

    Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.

    Product
    Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0597-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0595-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0594-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0593-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk

    Cook Inc. is recalling 458 Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2021·2020-10-28

    Boston Scientific Recalls Opticross 35 Peripheral Imaging Catheters

    Boston Scientific is recalling 41 Opticross 35 Peripheral Imaging Catheters because length markings may flake off during manipulation. No patient harm has been reported.

    Product
    Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of p
    Category
    Medical Device
    Distribution
    Distributed nationwide