The Recall Desk

Hazard

Guidewire Obstruction recalls

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

What the numbers show

Total
13
Critical
0
Severe
8
Most recent
2026-04-29

Of the 13 guidewire obstruction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (62%) 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 guidewire obstruction 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.

1–13 of 13

  • SevereFDA (Devices)·Z-1867-2026·2026-04-29

    Soft-Vu Angiographic Catheter Soft-Vu SO1 recalled for manufacturing defect

    Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2026·2026-04-29

    Soft-Vu Angiographic Catheter Headhunter recalled due to manufacturing defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided devices because a manufacturing defect may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2026·2026-04-29

    AccuVu Angiographic Catheter recalled for guidewire passage defect

    Angiodynamics is recalling the AccuVu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a properly sized guidewire from passing through the catheter hub's inner diameter.

    Product
    AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2026·2026-04-29

    Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided recalled for manufacturing defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The defect affects 1,550 units distributed worldwide.

    Product
    Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2026·2026-04-29

    Soft-Vu pigtail angiographic catheters may block the appropriately sized guidewire

    Soft-Vu Pigtail Angiographic Catheters are being recalled because a manufacturing defect may prevent an appropriately sized guidewire from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2026·2026-04-29

    Soft-Vu Angiographic Catheter Angiodynamics Guidewire Passage Defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The catheters were distributed worldwide including the US.

    Product
    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1663-2024·2024-05-22

    Expo 5F cardiac catheters recalled for material delamination

    Boston Scientific Corporation recalls Expo 5F cardiac catheters due to polyurethane layer delamination and inner lining detachment that prevents guidewire advancement. Affected batch 60535890 has been distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1655-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific recalled Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in certain batches, which can prevent guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1684-2024·2024-05-22

    Expo 5F Cardiac Catheters recalled due to delamination defect

    Boston Scientific is recalling 8,715 Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane delamination that prevents guidewire advancement. The affected units were distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1659-2024·2024-05-22

    Expo selective angiographic cardiac catheters recalled for guidewire advancement failure

    Boston Scientific is recalling Expo 5F selective angiographic catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1656-2024·2024-05-22

    Selective Angiographic Catheters Recalled Due to Material Delamination

    Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter lining, which may prevent guidewire advancement during medical procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1640-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters recalled due to material delamination

    Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane layer delamination that prevents guidewire advancement. The inner lining material may detach, making the catheters unsafe to use.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1670-2024·2024-05-22

    Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination Risk

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in the inner lining. The defect prevents guidewire advancement through the catheter, compromising its function during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states