PlainRecalls

Boston Scientific Corporation

Compiled from official public sources by the publisher.

632 recalls on record · Latest: Aug 12, 2026

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Agency notice ledger

Federal filing book Boston Scientific Corporati… HEAVY-BOOK · SINGLE-AGENCY

#10 of 14,151 · 632 notices · 0.605% archive

  • BOOK 632 notices
  • RANK #10 of 14,151
  • SHARE 0.605% archive
  • AGENCY FDA Devices (632)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 12, 2026
  • PHOTO Garden Fresh Foods, I…

Nearest notice-volume peer: Garden Fresh Foods, Inc. (2 notice gap)

Boston Scientific Corporation sits #10 of 14,151 (10th among 14,151 firms) with 632 federal notices — about 0.605% of the archive (heavy-book tercile). Rank counts issuance frequency, not danger. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Boston Scientific Corporati… sits among 14,151 recalling firms

Boston Scientific Corporation ranks 10th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Boston Scientific Corporati… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

632 10th of 14151 higher than 14,141 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Boston Scientific Corporati… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Boston Scientific Corporation carries 632 distinct federal notices, ranked #10 of 14,151 (heavy-book).

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jun 25, 2014

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.
FDA Devices Moderate Jun 25, 2014

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.
FDA Devices Moderate Jun 25, 2014

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.
FDA Devices Moderate Apr 30, 2014

iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
FDA Devices Moderate Mar 19, 2014

Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
FDA Devices Moderate Feb 19, 2014

Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
FDA Devices Moderate Feb 19, 2014

Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
FDA Devices Moderate Feb 5, 2014

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 sheath and a 0.035 guidewire.
FDA Devices Moderate Jan 22, 2014

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 retrieval device for foreign body objects, such as polyps and food boluses.
FDA Devices Moderate Jan 22, 2014

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 occluding the duct with the balloon.
FDA Devices Moderate Jan 22, 2014

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, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.
FDA Devices Moderate Jan 22, 2014

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 body objects, such as polyps and food boluses.
FDA Devices Moderate Jan 22, 2014

Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
FDA Devices Moderate Jan 22, 2014

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 body objects, such as polyps and food boluses.
FDA Devices Moderate Jan 22, 2014

Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
FDA Devices Moderate Jan 22, 2014

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 device for foreign body objects, such as polyps and food boluses.
FDA Devices Moderate Jan 22, 2014

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 device for foreign body objects, such as polyps and food boluses.
FDA Devices Moderate Dec 11, 2013

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.
FDA Devices Moderate Dec 11, 2013

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.
FDA Devices Moderate Dec 11, 2013

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.
FDA Devices Moderate Sep 11, 2013

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) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. 2) 4.00mm x 15mm Small Perip
FDA Devices Moderate Sep 11, 2013

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 FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015 The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries f
FDA Devices Moderate Jul 24, 2013

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 Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonis
FDA Devices Low Jul 17, 2013

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.
FDA Devices Moderate Jul 17, 2013

NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
FDA Devices Moderate Jul 17, 2013

NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
FDA Devices Moderate Oct 24, 2012

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.
FDA Devices Moderate Oct 24, 2012

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 soft tissues, including partial or complete ablation of nonresectable liver lesions.
FDA Devices Moderate Oct 24, 2012

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 nonresectable liver lesions.
FDA Devices Moderate Jun 27, 2012

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-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
FDA Devices Moderate Jun 27, 2012

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 three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
FDA Devices Moderate Jun 27, 2012

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-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop

Boston Scientific Corporati… sits in the heavy federal notice book

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (632 here — heavy-book).

Garden Fresh Foods, Inc. 634 Icu Medical, Inc. 657 Newly Weds Foods, Inc. 657 Siemens Healthcare Diagnostics, Inc. 665 Customed, Inc 682

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Icu Medical, Inc. 657 Siemens Healthcare Diagnostics, Inc. 665 Customed, Inc 682 Medline Industries, LP 486

Frequently Asked Questions

How many federal recall notices name Boston Scientific Corporati…? ▼
PlainRecalls indexes 632 distinct federal recall events naming Boston Scientific Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Boston Scientific Corporati… sit among other recalling firms? ▼
Boston Scientific Corporation ranks #10 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Boston Scientific Corporati…'s notices? ▼
FDA Devices accounts for 632 of this firm's 632 indexed notices.
What product category dominates Boston Scientific Corporati…'s filing book? ▼
Filings for Boston Scientific Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Boston Scientific Corporation: 632 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Boston Scientific Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026