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.

626–639 of 639

  • HighFDA (Devices)·Z-0442-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 449 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 274 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2137-2013·2013-09-11

    Boston Scientific Recalls Small Peripheral Cutting Balloon Catheters

    Boston Scientific is recalling 4.0mm x 15mm Small Peripheral Cutting Balloon catheters because users may be unable to remove the protector cap from the device.

    Product
    Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.0
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2138-2013·2013-09-11

    Boston Scientific Recalls 4.0mm Flextome Cutting Balloon Devices

    Boston Scientific is recalling 4.0mm x 15mm Flextome Cutting Balloon devices because users may be unable to remove the protector cap.

    Product
    Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm F
    Category
    Medical Device
    Distribution
    43 states
  • LowFDA (Devices)·Z-1748-2013·2013-07-24

    Boston Scientific Recalls Alair Bronchial Thermoplasty Catheters Due to Labeling Error

    Boston Scientific is recalling 35 units of Alair Bronchial Thermoplasty Catheters because the expiration date on the inner tray is incorrect.

    Product
    Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2013·2013-07-17

    Boston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error

    Boston Scientific is recalling 15 NephroMax high pressure nephrostomy Balloon Catheter Kits because an incorrectly sized renal sheath was packaged with the device.

    Product
    NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1672-2013·2013-07-17

    Boston Scientific Recalls NephroMax Balloon Catheters Due to Incorrect Sheath Packaging

    Boston Scientific is recalling 27 NephroMax high pressure nephrostomy balloon catheters because they were packaged with incorrectly sized renal sheaths.

    Product
    NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1671-2013·2013-07-17

    Boston Scientific Recalls Rigiflex Balloon Dilator for Incorrect Expiration Date

    Boston Scientific is recalling 91 units of the Rigiflex Single-Use Achalasia Balloon Dilator because they were labeled with an incorrect expiration date.

    Product
    RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0081-2013·2012-10-24

    Boston Scientific Recalls Leveen Coaccess Introducer Sets for Incorrect Portuguese Instructions

    Boston Scientific is recalling 19,716 Leveen Coaccess Introducer Sets because the Portuguese instructions for use contain errors. The devices were distributed in Brazil, Portugal, and Hong Kong.

    Product
    Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0080-2013·2012-10-24

    Boston Scientific Recalls Leveen Needle Electrodes Due to Incorrect Portuguese Instructions

    Boston Scientific is recalling Leveen Coaccess Needle Electrodes because the Portuguese instructions for use contain errors. The recall affects units distributed in Brazil, Portugal, and Hong Kong.

    Product
    Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresect
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0079-2013·2012-10-24

    Boston Scientific Recalls LeVeen Needle Electrode Systems for Incorrect Portuguese Instructions

    Boston Scientific is recalling LeVeen Standard Needle Electrode Systems because the Portuguese instructions for use are incorrect. The recall affects units distributed in Brazil, Portugal, and Hong Kong.

    Product
    LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1852-2012·2012-06-27

    Boston Scientific Recalls Pediatric Polypectomy Snares Due to Extension Difficulty

    Boston Scientific is recalling 1,340 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2012·2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling 1,970 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1850-2012·2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling Profile Single-Use Pediatric Snares due to difficulty extending the snare loop from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a thre
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.