The Recall Desk

Manufacturer

Boston Scientific Corporation

639 recalls in our database name Boston Scientific Corporation as the manufacturing or recalling firm.

What the numbers show

Total
639
Critical
57
Severe
102
Most recent
2026-09-09

Of the 639 recalls from Boston Scientific Corporation we have scored against our rubric, 57 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 102 (16%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

226–250 of 639

  • SevereFDA (Devices)·Z-1650-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment in the catheter's inner lining, which prevents proper advancement of the guidewire.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; 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-1651-2024·2024-05-22

    Boston Scientific Cardiac Catheters Recalled for Material Delamination

    Boston Scientific recalled Expo 5F cardiac catheters due to polyurethane delamination preventing guidewire advancement. The defect may cause device failure during medical procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1643-2024·2024-05-22

    Cardiac catheters recalled due to polyurethane layer delamination defects

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer defects that prevent proper guidewire insertion. Affected devices may experience material detachment in the catheter lining.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; 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-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
  • SevereFDA (Devices)·Z-1648-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters recalled for delamination risk

    Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in select batches due to polyurethane layer delamination and material detachment that could prevent guidewire advancement during use.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1662-2024·2024-05-22

    Cardiac Catheters Recalled for Material Delamination Risk

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters worldwide due to polyurethane delamination and material detachment that prevents guidewire advancement.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1661-2024·2024-05-22

    Expo Cardiac Catheters Recalled Due to Polyurethane Delamination and Material Detachment

    Boston Scientific's Expo 5F Selective Angiographic Catheters are being recalled worldwide because the polyurethane layer is delaminating and detaching from the inner lining, preventing the guidewire from advancing through the device.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; 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-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-1638-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific is recalling Expo 5F catheters due to polyurethane delamination and material detachment preventing guidewire advancement. The recall affects approximately 16,797 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1678-2024·2024-05-22

    Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Failure

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

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1677-2024·2024-05-22

    Cardiac Catheters Recalled Due to Defective Polyurethane Layer

    Boston Scientific recalls 1,015 Expo 5F selective angiographic catheters due to polyurethane layer delamination that prevents guidewire advancement. The defect affects multiple batches distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; 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-1672-2024·2024-05-22

    Expo Cardiac Catheters Recalled Due to Delamination and Guidewire Advancement Failure

    Boston Scientific has recalled Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The defect affects certain batch numbers in catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1668-2024·2024-05-22

    Boston Scientific Expo 5F Cardiac Catheters Recalled for Delamination Defect

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination that prevents guidewire advancement during cardiac procedures. The recall affects 86,898 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1679-2024·2024-05-22

    Boston Scientific Expo 5F Catheters recalled due to material delamination defect

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

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1680-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

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

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1642-2024·2024-05-22

    Boston Scientific Cardiac Catheters Recalled for Material Delamination

    Boston Scientific is recalling certain Expo 5F cardiac catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during procedures. The recall affects 290 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • 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-1639-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Polyurethane Delamination

    Expo 5F Selective Angiographic Catheters are recalled because polyurethane layer delamination and material detachment prevent guidewire advancement. Approximately 297,479 affected catheters have been distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1673-2024·2024-05-22

    Boston Scientific Cardiac Catheters Recalled for Inner Lining Delamination

    Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the inner lining, which can prevent guidewire advancement.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1682-2024·2024-05-22

    Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Malfunction

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in eight batches affecting 4942 units. The defect prevents guidewire advancement and could compromise device function during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1666-2024·2024-05-22

    Boston Scientific Expo 5F catheters recalled for material delamination

    Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The recall affects 46,860 units distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Boston Scientific

worldwide developer, manufacturer and marketer of medical devices

Country
United States
Founded
1979

Official website

Source: Wikidata (Q894585), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.