GLOBAL ICON 1140-20-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295381280), received between Aug 26, 2019 and Oct 14, 2021 — classified as 5 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR PAROXYSMAL ATRIAL FIBRILLATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT SHOULDER). TREATMENT: HOSPITALIZATION WITH MEDICAL INTERVENTION (UNSPECIFIED).

  Patient problems: Arrhythmia

  MAUDE report 12631397 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PNEUMONIA. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT SHOULDER). TREATMENT: HOSPITALIZATION WITH MEDICAL INTERVENTION (UNSPECIFIED).

  Patient problems: Pneumonia

  MAUDE report 12631353 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED. UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED, FOR PAIN IN RIGHT BICEPS TENDON. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018, DATE OF EVENT: (B)(6) 2021. (RIGHT SHOULDER). TREATMENT: MARCAINISATION.

  Patient problems: Pain

  MAUDE report 12066943 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SILENT INFERIOR MYOCARDIAL INFARCTION EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE EVENT: THERE IS A REMOTE POSSIBILITY THAT IT IS RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION:(B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT SHOULDER).

  Patient problems: Myocardial Infarction

  MAUDE report 9155958 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PNEUMONIA AND PAROXYSMAL ATRIAL FIBRILLATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018, DATE OF EVENT: (B)(6) 2019, (LEFT SHOULDER).

  Patient problems: Atrial Fibrillation; Pneumonia

  MAUDE report 8932259 ↗