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.

476–500 of 639

  • ModerateFDA (Devices)·Z-0548-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 109 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2020·2019-12-04

    Boston Scientific Pancreatic Stent Recall Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0555-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents with Incorrect Shelf Life Labeling

    Boston Scientific is recalling Advanix Pancreatic Stents labeled with a 36-month shelf life instead of the approved 18-month duration.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0556-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 139 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0557-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 271 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 97 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0559-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 179 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0552-2020·2019-12-04

    Boston Scientific Pancreatic Stent Recall Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 940 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2020·2019-12-04

    Boston Scientific Pancreatic Stent Recall Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month period.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0579-2020·2019-12-04

    Boston Scientific Recalls NC Emerge Monorail PTCA Catheters for Coating Defect

    Boston Scientific is recalling NC Emerge Monorail PTCA Dilatation Catheters because they may be missing a hydrophilic coating step during manufacturing.

    Product
    NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H74939
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2020·2019-12-04

    Boston Scientific Recalls Advanix Pancreatic Stents Due to Shelf Life Labeling Error

    Boston Scientific is recalling 54 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.

    Product
    Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2543-2019·2019-09-25

    Boston Scientific Recalls S-ICD Devices Due to Battery Depletion

    Boston Scientific is recalling 404 EMBLEM MRI S-ICD devices because a compromised electrical component causes accelerated battery depletion, potentially requiring earlier replacement.

    Product
    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2019·2019-09-25

    Boston Scientific Recalls 28 Subcutaneous Implantable Cardioverter Defibrillators

    Boston Scientific is recalling 28 EMBLEM S-ICD devices due to accelerated battery depletion. Patients should contact their healthcare provider for evaluation.

    Product
    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2019·2019-09-11

    Boston Scientific Recalls Mislabeled AMS 800 Artificial Urinary Sphincter Cuffs

    Boston Scientific is recalling AMS 800 Artificial Urinary Sphincter belt cuffs labeled as 4.5 cm but measuring 4.0 cm due to mislabeling.

    Product
    AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1397-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling 18 Auriga 30 laser systems worldwide because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, exc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1393-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems Due to Power Degradation

    Boston Scientific is recalling three Auriga XL 4007 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perfo
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1392-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

    Boston Scientific is recalling 27 Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause the device to stop emitting laser pulses during surgery.

    Product
    AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1395-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling eight Auriga 30 laser systems worldwide because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, exci
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1398-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inci
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1399-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling two Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and a low power error.

    Product
    AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1394-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

    Boston Scientific is recalling six Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause power degradation and stop laser emission.

    Product
    AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perfo
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1396-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1391-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser System for Cooling Defect

    Boston Scientific is recalling specific Auriga XL 4007 laser systems due to a mechanical cooling issue that may cause premature power degradation and low power errors.

    Product
    AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
    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.