The Recall Desk

Manufacturer

Boston Scientific Corporation

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

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.

26–50 of 336

  • Severity pendingFDA (Devices)·Z-1042-2026·2026-01-21

    Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm,

    Pending LLM rewrite. Source: FDA_DEVICE Z-1042-2026.

    Product
    Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-0139-2026·2025-10-22

    TENACIO Pump without InhibiZone; UPN: 72404420;

    Pending LLM rewrite. Source: FDA_DEVICE Z-0139-2026.

    Product
    TENACIO Pump without InhibiZone; UPN: 72404420;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-0094-2026·2025-10-22

    Model Number L110, ESSENTIO SR SL MRI Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0094-2026.

    Product
    Model Number L110, ESSENTIO SR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0081-2026·2025-10-22

    ACCOLADE SR SL MRI (Model L310)

    Pending LLM rewrite. Source: FDA_DEVICE Z-0081-2026.

    Product
    ACCOLADE SR SL MRI (Model L310)
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0090-2026·2025-10-22

    Model Number L221 PROPONENT DR EL Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0090-2026.

    Product
    Model Number L221 PROPONENT DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0142-2026·2025-10-22

    CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431

    Pending LLM rewrite. Source: FDA_DEVICE Z-0142-2026.

    Product
    CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-0097-2026·2025-10-22

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0097-2026.

    Product
    Model Number L131, ESSENTIO DR EL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0085-2026·2025-10-22

    PROPONENT SR SL (Model L200)

    Pending LLM rewrite. Source: FDA_DEVICE Z-0085-2026.

    Product
    PROPONENT SR SL (Model L200)
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0088-2026·2025-10-22

    Model Number L210 PROPONENT SR SL Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0088-2026.

    Product
    Model Number L210 PROPONENT SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0098-2026·2025-10-22

    Model Number S701 ALTRUA 2 SR SL Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0098-2026.

    Product
    Model Number S701 ALTRUA 2 SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0100-2026·2025-10-22

    Model Number S722, ALTRUA 2 DR EL Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0100-2026.

    Product
    Model Number S722, ALTRUA 2 DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0095-2026·2025-10-22

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0095-2026.

    Product
    Model Number L111, ESSENTIO DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0082-2026·2025-10-22

    ACCOLADE DR SL MRI (Model L311)

    Pending LLM rewrite. Source: FDA_DEVICE Z-0082-2026.

    Product
    ACCOLADE DR SL MRI (Model L311)
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0101-2026·2025-10-22

    Model Number U125, VALITUDE CRT-P EL

    Pending LLM rewrite. Source: FDA_DEVICE Z-0101-2026.

    Product
    Model Number U125, VALITUDE CRT-P EL
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0104-2026·2025-10-22

    Model Number U226, VISIONIST CRT-P EL

    Pending LLM rewrite. Source: FDA_DEVICE Z-0104-2026.

    Product
    Model Number U226, VISIONIST CRT-P EL
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0102-2026·2025-10-22

    Model Number U128, VALITUDE CRT-P EL MRI

    Pending LLM rewrite. Source: FDA_DEVICE Z-0102-2026.

    Product
    Model Number U128, VALITUDE CRT-P EL MRI
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0079-2026·2025-10-22

    ACCOLADE SR SL (Model L300)

    Pending LLM rewrite. Source: FDA_DEVICE Z-0079-2026.

    Product
    ACCOLADE SR SL (Model L300)
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0092-2026·2025-10-22

    Model Number L100, ESSENTIO SR SL Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0092-2026.

    Product
    Model Number L100, ESSENTIO SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0138-2026·2025-10-22

    TENACIO Pump with InhibiZone; UPN: 72404429;

    Pending LLM rewrite. Source: FDA_DEVICE Z-0138-2026.

    Product
    TENACIO Pump with InhibiZone; UPN: 72404429;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-0096-2026·2025-10-22

    Model Number L121 ESSENTIO DR EL Pacemaker

    Pending LLM rewrite. Source: FDA_DEVICE Z-0096-2026.

    Product
    Model Number L121 ESSENTIO DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0144-2026·2025-10-22

    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 7240445

    Pending LLM rewrite. Source: FDA_DEVICE Z-0144-2026.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-0084-2026·2025-10-22

    ACCOLADE DR EL MRI (Model L331)

    Pending LLM rewrite. Source: FDA_DEVICE Z-0084-2026.

    Product
    ACCOLADE DR EL MRI (Model L331)
    Category
    Medical Device
    Distribution
    0 states