Manufacturer
639 recalls in our database name Boston Scientific Corporation as the manufacturing or recalling firm.
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.
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.
Boston Scientific is recalling Hurricane RX dilation balloons used in endoscopic biliary procedures due to pinhole defects causing pressure loss that may prolong treatment.
Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.
Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.
Boston Scientific is recalling TheraSphere Administration Sets due to potential leaks and loosening at the patient catheter connection. Approximately 4,200 sets were distributed worldwide.
Boston Scientific is recalling TheraSphere Administration Sets due to potential for leaks and loosening at the patient catheter connection. The recall affects 4980 sets distributed worldwide.
Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.
Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.
The INTUA CRT-P pacemakers (1,707 units) may develop high internal battery impedance later in device life, causing system resets and triggering Safety Mode. Therapy continues but device replacement is required.
Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.
Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.
Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.
Boston Scientific has recalled certain Proponent pacemaker models worldwide. Hydrogen gas may accumulate inside the device, compromising the capacitor and causing accelerated battery depletion.
Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.
Boston Scientific VALITUDE CRT-P pacemakers (models U125 and U128) may experience hydrogen release that compromises the capacitor, causing accelerated battery depletion. Patients should consult their healthcare provider.
Boston Scientific is recalling 2,952 Altrua 2 pacemaker units (models S701, S702, S722) distributed worldwide due to hydrogen release that can damage the capacitor and accelerate battery depletion.
Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.
Boston Scientific is recalling six Essentio pacemaker models due to a hydrogen release defect that may compromise a critical capacitor and cause accelerated battery depletion. Approximately 31,548 units worldwide are affected.
Boston Scientific is recalling VICI RDS Venous Stent Systems manufactured between May 2018 and April 2021 due to reports of stent migration after implantation.
Boston Scientific is recalling VICI Venous Stent Systems because the company received reports of stent migration after implantation.
Boston Scientific is recalling 27 units of the ELUVIA Drug-Eluting Vascular Stent System because some 6x40mm stents were incorrectly placed in 6x100mm packaging.
Boston Scientific is recalling Colpassist Vaginal Positioning Devices due to potential pinholes that may compromise sterility and cause post-operative infection.
Boston Scientific is recalling Upsylon Y Mesh Kits because pinholes may breach the sterile barrier, potentially rendering the device non-sterile and causing post-operative infection.
Boston Scientific is recalling three EXALT Controllers because they may have been programmed with suboptimal brightness settings, resulting in darker than desired images.
Boston Scientific is recalling 23 AMS 700 penile prosthesis reservoirs because they were incorrectly labeled as a different model type.
Boston Scientific is recalling 63 MAMBA Microcatheters due to incorrect labeling and packaging. The devices were distributed nationwide and internationally.
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
Source: Wikidata (Q894585), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.