BOSTON SCIENTIFIC CORP

BOSTON SCIENTIFIC CORP is tracked across 3 federal verticals with 49 regulatory events in the last 365 days. Every event below traces to a primary US-government source listed in the References section.

Identifiers

• SEC CIK 0000885725
• Ticker BSX

Activity breakdown

• FDA recalls + warnings 43 [1]
• Clinical trials 5 [2]
• open 1

Timeline

1. 2026-08-06 FDA recall Boston Scientific Corporation Class II
   There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic inte
2. 2026-08-06 FDA recall Boston Scientific Corporation Class II
   There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic inte
3. 2026-08-06 FDA recall Boston Scientific Corporation Class II
   There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic inte
4. 2026-07-14 FDA recall Boston Scientific Corporation Class II
   Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
5. 2026-07-14 FDA recall Boston Scientific Corporation Class II
   Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
6. 2026-07-09 FDA recall Boston Scientific Corporation Class I
   Potential for arterial sheath tip separation or partial tip separation during use.
7. 2026-07-09 FDA recall Boston Scientific Corporation Class I
   Potential for arterial sheath tip separation or partial tip separation during use.
8. 2026-06-30 FDA recall Boston Scientific Corporation Class II
   Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficu
9. 2026-06-19 FDA recall Boston Scientific Corporation Class II
   Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is update
10. 2026-06-11 FDA recall Boston Scientific Corporation Class II
    Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in
11. 2026-06-11 FDA recall Boston Scientific Corporation Class II
    Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
12. 2026-06-11 FDA recall Boston Scientific Corporation Class II
    Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
13. 2026-06-11 FDA recall Boston Scientific Corporation Class II
    Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
14. 2026-06-11 FDA recall Boston Scientific Corporation Class II
    Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
15. 2026-06-11 FDA recall Boston Scientific Corporation Class II
    Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in
16. 2026-06-11 FDA recall Boston Scientific Corporation Class II
    Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in
17. 2026-06-11 FDA recall Boston Scientific Corporation Class II
    Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in
18. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
19. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
20. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
21. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
22. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
23. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
24. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
25. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
26. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
27. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
28. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
29. 2026-05-21 FDA recall Boston Scientific Corporation Class II
    Potential sterile breach of the pouches in which devices are packaged.
30. 2026-05-12 FDA recall Boston Scientific Corporation Class II
    Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
31. 2026-05-11 FDA recall Boston Scientific Corporation Class II
    There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
32. 2026-05-06 Clinical trial Boston Scientific Corporation AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE
    Sponsor Decision
33. 2026-04-27 Clinical trial Boston Scientific Corporation A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
    ["In-Stent Restenosis"]
34. 2026-04-27 Clinical trial Boston Scientific Corporation A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
    ["In-Stent Restenosis"]
35. 2026-04-17 Clinical trial Boston Scientific Corporation Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis
    Sponsor decision
36. 2026-04-08 Clinical trial Boston Scientific Corporation MANDARIN (S6371)
    ["Inoperable Hepatocellular Carcinoma"]
37. 2026-03-30 FDA recall Boston Scientific Corporation Class II
    For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices
38. 2026-03-30 FDA recall Boston Scientific Corporation Class II
    For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices
39. 2026-03-19 FDA recall Boston Scientific Corporation Class I
    Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P
40. 2026-03-19 FDA recall Boston Scientific Corporation Class I
    Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P
41. 2026-02-10 FDA recall Boston Scientific Corporation Class II
    Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside
42. 2025-12-19 FDA recall Boston Scientific Corporation Class I
    Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most seriou
43. 2025-12-19 FDA recall Boston Scientific Corporation Class I
    Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most seriou
44. 2025-12-19 FDA recall Boston Scientific Corporation Class I
    Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most seriou
45. 2025-12-19 FDA recall Boston Scientific Corporation Class I
    Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most seriou
46. 2025-12-19 FDA recall Boston Scientific Corporation Class I
    Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most seriou
47. 2025-12-19 FDA recall Boston Scientific Corporation Class I
    Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most seriou
48. 2025-12-03 FDA recall Boston Scientific Corporation Class II
    Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use
49. 2024-12-31 open.payments Boston Scientific Corporation $49002919.0 to 68994 physicians (2024–2024) $49.00M
    WATCHMAN Access System