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 4,500 EMBLEM S-ICD Programmer Model 3200 units due to a potential risk of radio frequency interference causing unintended commands during in-clinic sessions.
Boston Scientific is recalling INGEVITY MRI endocardial pacing leads because the polyurethane boot may not be securely connected to the lead body.
Boston Scientific is recalling five implanted pacemakers that used an unapproved module configuration. The devices were shipped to customers in five states.
Boston Scientific is recalling four Ultraflex Tracheobronchial stents because 10mm diameter units were mislabeled as 12mm diameter.
Boston Scientific is recalling Fetch 2 Aspiration Catheters because the catheter shafts may break, potentially requiring additional procedures to remove the broken piece from patients.
Boston Scientific is voluntarily recalling PT Graphix Magnet J-TIP Guidewires because the wires are straight instead of having the pre-formed J-tip.
Boston Scientific is recalling five MRI PROPONENT SR pacemakers because the included literature incorrectly describes the device's pacing mode.
Boston Scientific is recalling three PROPONENT MRI DR pacemakers because the included literature packet incorrectly describes the device type.
Boston Scientific is recalling ACUITY Pro Coronary Sinus Guide Catheters due to a potential for the proximal handle to separate from the shaft.
Boston Scientific is voluntarily recalling Chariot Guiding Sheaths after receiving complaints about shaft separation, which could lead to embolism of device fragments.
Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices because of complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.
Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices due to complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.
Boston Scientific is recalling three SQ-RX Model 1010 subcutaneous pulse generators shipped in dual-channel mode. This configuration may delay initial telemetry scans but does not affect therapy delivery.
Boston Scientific is recalling WATCHMAN Access System sheaths because the hemostasis valve may cross-thread if tightened with the dilator in place, potentially preventing the valve from sealing.
Boston Scientific is issuing a field correction for WATCHMAN Left Atrial Appendage Closure Devices to prevent hemostasis valve cross-threading and potential blood leakage.
Boston Scientific is recalling nine AngioJet AVX Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.
Boston Scientific is recalling nine AngioJet Spiroflex Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.
Boston Scientific is recalling 9 AngioJet SOLENT Dista Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.
Boston Scientific is recalling 9 AngioJet SOLENT Omni Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.
Boston Scientific is recalling one lot of Extractor Pro RX Retrieval Balloon Catheters because the device contains a syringe size larger than what is identified on the label.
Boston Scientific is recalling 43 CLEARSIGN II Amplifiers because blood pressure channel usage can cause ECG signals to become uninterpretable.
Boston Scientific is recalling specific lots of Expel Drainage Catheters because they may fragment after implantation, potentially requiring additional medical procedures to remove the pieces.
Boston Scientific is recalling Expel APD and APDL Drainage Catheters after one report of device fragmentation in the biliary system.
Boston Scientific is recalling 278 units of the Lotus TAVR 23mm valve because the device may unlock during release, potentially causing the valve to embolize.
Boston Scientific is recalling 278 units of the Lotus TAVR 27mm valve because the device may unlock during release, potentially causing the valve to embolize.
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.