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.

601–625 of 639

  • HighFDA (Devices)·Z-0916-2015·2015-01-21

    Boston Scientific Recalls Lotus TAVR Valve Prosthesis Due to Unlocking Risk

    Boston Scientific is recalling Lotus TAVR 25mm valve prostheses because the valve may unlock during release, potentially requiring additional procedures or surgery.

    Product
    Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific ao
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1798-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1487-2014·2014-04-30

    Boston Scientific Recalls iLab Ultrasound Systems Due to Measurement Error

    Boston Scientific is recalling 9 iLab Ultrasound Imaging Systems because a software update may cause the Longview distance measurement to display double the actual value.

    Product
    iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2014·2014-03-19

    Boston Scientific Recalls RunWay Guide Catheters Due to Sterility Concerns

    Boston Scientific is recalling seven RunWay Guide Catheters because their sterile pouches may not be completely sealed, potentially compromising sterility.

    Product
    Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0969-2014·2014-02-19

    Boston Scientific Recalls Coyote Balloon Dilation Catheters Due to Deflation Issues

    Boston Scientific is recalling specific lots of Coyote balloon dilation catheters because the balloons may not deflate as expected during procedures.

    Product
    Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0971-2014·2014-02-19

    Boston Scientific Recalls Coyote PTA Balloon Dilatation Catheters

    Boston Scientific is recalling Coyote PTA Balloon Dilatation Catheters because the balloons may not deflate as expected during procedures.

    Product
    Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0900-2014·2014-02-05

    Boston Scientific Recalls 1068 Peripheral Imaging Catheters Due to Guidewire Issues

    Boston Scientific is recalling 1,068 units of the Atlantis PV 8.5F Peripheral Imaging Catheter because physicians reported an inability to pass a guidewire through the device.

    Product
    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0723-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues

    Boston Scientific is recalling TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a retrieval
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity

    Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity

    Boston Scientific is recalling 3,300 TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Nat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2014·2014-01-22

    Boston Scientific Recalls Twister Plus Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 253 Twister Plus 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 425 TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign bod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2014·2014-01-22

    Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters

    Boston Scientific is recalling 38 units of Extractor Pro XL Retrieval Balloon Catheters due to potential defects in skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2014·2014-01-22

    Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters

    Boston Scientific is recalling 39 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occludin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0712-2014·2014-01-22

    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter Recall

    Boston Scientific is recalling 34 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

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

    Product
    Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, 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

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.