superDimension SDBF1000 (UDI 10884521200517)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521200517), received between Dec 5, 2017 and Nov 26, 2024 — classified as 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE BLEEDING OCCURRED AFTER THE BIOPSY OF THE LEFT UPPER LOBE. CARDIOPULMONARY RESUSCITATION WAS PERFORMED TO THE PATIENT. THE EVENT HAS LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE PATIENT WAS TRANSFERRED AND STILL IN THE INTENSIVE CARE UNIT AND REMAINED EXTUBATED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20781099 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD PNEUMOTHORAX. TO RESOLVE THE ISSUE, THE SURGEON USED A CHEST TUBE. THE PATIENT HAD TO EXTEND HOSPITALIZATION FOR ONE DAY.

  Patient problems: Pneumothorax

  MAUDE report 15027199 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PHYSICIAN USED THE TOWER WITH A KIT, NAVIGATED TO THE TARGET AND USED RADIAL EBUS FOR CONFIRMATION. THEN USED THE FOLLOWING ENDOSCOPIC TOOLS; BRUSH, FORCEPS, AND SUPERTRAX NEEDLE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ENB PORTION OF THE CASE, HOWEVER, THE PATIENT EXPERIENCED BLEEDING. EPINEPHRINE, SALINE AND TAMPONADE TO RESOLVE THE BLEEDING. THE PHYSICIAN WAS ABLE TO TAMPONADE THE BIOPSY SITE WITH SCOPE TO CONTROL AND GET BLEEDING TO STOP. OUT OF AN ABUNDANCE OF CAUTION THE PATIENT WAS LEFT INTUBATED AND ADMITTED FOR OVERNIGHT OBSERVATION IN THE SURGICAL INTENSIVE CARE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11272490 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER A PNEUMOTHORAX WAS DISCOVERED AFTER THE CASE. THEY WERE NOT SURE WHICH DEVICE CAUSED THE EVENT. THE PATIENT IS STILL ADMITTED IN THE HOSPITAL.

  Patient problems: Pneumothorax

  MAUDE report 8501266 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED WAS PNEUMOTHORAX. MULTIPLE TOOLS WERE USED FOR BIOPSY. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE SUCCESSFULLY. THE PATIENT VISITED ER IN THE EVENING ON (B)(6) 2019. A PIGTAIL WAS PLACED.

  Patient problems: Pneumothorax

  MAUDE report 8279583 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED A PNEUMOTHORAX. A CHEST TUBE WAS INSERTED AND THE PATIENT WAS ADMITTED IN THE HOSPITAL. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE. THERE WAS NO ISSUES WITH THE BIOPSY FORCEPS, AND THE PHYSICIAN WAS UNABLE TO DETERMINE WHAT CAUSED THE PNEUMOTHORAX BECAUSE IT WAS DISCOVERED POSTOPERATIVELY.

  Patient problems: Pneumothorax

  MAUDE report 7506178 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2015, INTRA-OPERATIVELY, THE PATIENT EXPERIENCED MILD HEMOPTYSIS DURING THE ENB PROCEDURE, ESTIMATED BLOOD LOSS 35 ML. 2 ALIQUOTS OF EPINEPHRINE AND SALINE WERE ADMINISTERED FOR THE MILD HEMOPTYSIS.

  Patient problems: Blood Loss

  MAUDE report 7084176 ↗