The Recall Desk

Hazard

Material Delamination recalls

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

What the numbers show

Total
31
Critical
3
Severe
28
Most recent
2024-05-22

Of the 31 material delamination recalls we have scored against our rubric, 3 (10%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 28 (90%) 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 material delamination 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.

26–31 of 31

  • SevereFDA (Devices)·Z-1645-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters recalled for guidewire advancement failure

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that can prevent guidewire advancement during cardiac catheterization procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • 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-1653-2024·2024-05-22

    Expo 5F cardiac angiographic catheters recalled for delamination defect

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the catheter lumen.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1644-2024·2024-05-22

    Selective Angiographic Catheters recalled for material delamination and detachment

    Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect may prevent proper guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1654-2024·2024-05-22

    Expo 5F cardiac catheters recalled for material delamination worldwide

    Boston Scientific is recalling 2,990 Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the device lumen.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1676-2024·2024-05-22

    Expo 5F Catheters Recalled for Guidewire Advancement Failure

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The issue affects 440 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states