superDimensionRecalls & reported problems across all models

We found 20 models of superDimension by Covidien LP in the FDA's device registry (GUDID). Together they are named in 241 adverse event reports in the FDA's MAUDE database, received between Sep 22, 2016 and Sep 3, 2025 — classified as 45 deaths, 171 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (37 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported superDimension problems

superDimension models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• superDimension AAS00161-20

  System, x-ray, tomography, computed
  44 deaths190 reports
• superDimension SDBF1000

  INSTRUMENT, BIOPSY
  7 reports
• superDimension AKI00133-01

  INSTRUMENT, BIOPSY
  6 reports
• superDimension AAS00161-20

  System, x-ray, tomography, computed
  6 reports
• superDimension AKI00100-01

  endoscopic cytology brush
  5 reports
• superDimension SDAN1000

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  5 reports
• superDimension SDNB2000

  endoscopic cytology brush
  1 death3 reports
• superDimension SDMDK1000

  System, x-ray, tomography, computed
  2 reports
• superDimension SDTNB1000

  BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
  2 reports
• superDimension SDTNB1500

  BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
  2 reports
• superDimension SDBF1000

  INSTRUMENT, BIOPSY
  2 reports
• superDimension SDAN1000

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  2 reports
• superDimension SDAN2000

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  2 reports
• superDimension SDM2

  Accelerator, linear, medical
  1 report
• superDimension SDM3

  Accelerator, linear, medical
  1 report
• superDimension AAS00161-20R

  System, x-ray, tomography, computed
  1 report
• superDimension SDAN2000

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  1 report
• superDimension AED00170-01

  System, x-ray, tomography, computed
  1 report
• superDimension AKI00131-01

  System, x-ray, tomography, computed
  1 report
• superDimension SDTNB1000

  Brush, biopsy, bronchoscope (non-rigid)
  1 report

Recent superDimension adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A RETROSPECTIVE LITERATURE SOURCE OF A STUDY PERFORMED BETWEEN FEBRUARY 2016 AND DECEMBER 2019 TO COMPARE THE RESULTS OF 100 PATIENTS WHO UNDERWENT THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY-TRANSBRONCHIAL LUNG BIOPSIES (TBLBS) WITH THOSE OF 50 VIR TUAL BRONCHOSCOPY NAVIGATION (VBN)-TBLBS AT A SINGLE INSTITUTION. THE FIRST 35 PATIENTS UNDERWENT ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) WITHOUT FLUOROSCOPY GUIDANCE TWO OF WHOM (5.7%) REQUIRED THORACIC DRAINAGE FOR PNEUMOTHORAX. FLUOROSCOPIC GUIDANCE FOR TARGETS NEAR THE PLEURAL SURFACE WERE USED TO THE REMAINING 65 PATIENTS TO MINIMIZE RISK. ONLY TWO OF WHOM (3.1%) HAD PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 22952380 ↗
• MalfunctionSep 3, 2025Patient Data Problem; Patient Data Problem

  ACCORDING TO A RETROSPECTIVE LITERATURE SOURCE OF A STUDY PERFORMED BETWEEN FEBRUARY 2016 AND DECEMBER 2019 TO COMPARE THE RESULTS OF 100 PATIENTS WHO UNDERWENT THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY-TRANSBRONCHIAL LUNG BIOPSIES (TBLBS) WITH THOSE OF 50 VIR TUAL BRONCHOSCOPY NAVIGATION (VBN)-TBLBS AT A SINGLE INSTITUTION. COMPLICATIONS INCLUDED INCOMPLETE REGISTRATION IN TWO PATIENTS (2%).

  Patient problems: Insufficient Information

  MAUDE report 22952336 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN AUGUST 2014 AND JANUARY 2020, A RETROSPECTIVE STUDY EVALUATED THE DIAGNOSTIC YIELD OF ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY IN PATIENTS. THERE WERE 81 PROCEDURES PERFORMED ON 77 PATIENTS. ALL PROCEDURES WERE PERFORMED WITH THE SUPER-DIMENSION SYSTEM. GENCUT AND OTHER TOOLS WERE USED FOR DIAGNOSIS. POSTOPERATIVE COMPLICATIONS INCLUDED PNEUMOTHORAX AND MINOR BLEEDING FOR 2 CASES. CHEST TUBE PLACEMENT AND HOSPITALIZATION OCCURRED IN ONE PATIENT WITH PNEUMOTHORAX.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 22951569 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MARCH 2019 TO FEBRUARY 2024, A RETROSPECTIVE STUDY ANALYZED THE HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION WITH CONCOMITANT VIDEO-ASSISTED THORACOSCOPIC LUNG RESECTION. A TOTAL OF 92 PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 103 PROCEDURES PERFORMED AND 162 LUNG NODULES TREATED 142 LUNG NODULES WERE ABLATED AND 20 LUNG NODULES WERE RESECTED. 6 PATIENTS HAD COMPLICATIONS INCLUDING (1) PERSISTED FEVER, (2) AIRWAY BLEEDING, (2) PNEUMOTHORAX AND (1) BRONCHOPLEURAL FISTULA. ORAL ANTIBIOTICS WERE GIVEN, CHEST TUBE DRAINAGE WAS DONE AND ENDOBRONCHIAL VALVE PLACEMENT ON. RE-ADMISSION WAS REQUIRED. HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION. DR. CALVIN NG, 2025, INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY.

  Patient problems: Fever; Fistula; Pneumothorax

  MAUDE report 22926491 ↗
• MalfunctionMar 19, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A LABELING ISSUE WITH THE PATIENT SENSOR PATCH PACKAGE. THE CUSTOMER CHECKED THE DELIVERED SENSOR PATCH PACKAGE AND NOTICED A SHORT USE BY DATE OF 2025-08-21, DESPITE THE MANUFACTURING DATE BEING 2025-01-23, INDICATING A POSSIBLE LABELING ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649164 ↗
• InjuryMar 13, 2025Poor Quality Image; Failure to Power Up; Application Program Problem; Poor Quality Image; Failure to Power Up; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE PROCEDURE WAS NOT COMPLETED AS THE SYSTEMS SCREEN WENT BLACK DURING THE PROCEDURE AND THE PHYSICIAN COULD NOT GET IT BACK ON. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE SUPER DIMENSION PORTION OF THE CASE. AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) WAS DONE TO COMPLETE THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594629 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE, A RETROSPECTIVE STUDY ANALYZED THE LEARNING CURVE OF ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) IN PATIENTS WITH SMALL PERIPHERAL PULMONARY NODULES BETWEEN NOVEMBER 2019 AND DECEMBER 2021. SUPERDIMENSION WAS USED TO RECONSTRUCT THE VIRTUAL BRONCHUS RECONSTRUCTION AND IDENTIFY THE PATHWAY TO THE TARGET LESION. COMPLICATIONS RELATED TO THE ENB PROCEDURE INCLUDED PNEUMOTHORAX IN TWO PATIENTS. INTERVENTIONS WERE NOT REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 21124944 ↗
• 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 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN AUGUST 2021 AND JUNE 2023, THE RESULTS OF THE VERITAS TRIAL, NAVIGATIONAL BRONCHOSCOPY (NB) WAS COMPARED TO COMPUTED TOMOGRAPHY-GUIDED TRANSTHORACIC NEEDLE BIOPSY. A TOTAL OF 234 PATIENTS WITH PERIPHERAL LUNG NODULES UNDERWENT BIOPSY PROCEDURES. NB WAS PERFORMED IN 121 PATIENTS. PER THE STUDY PROTOCOL, SUPERDIMENSION ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY PLATFORM WITH DIGITAL TOMOSYNTHESIS CAPABILITY WAS USED FOR ALL NB PROCEDURES. COMPLICATIONS IN THE NB GROUP INCLUDED PNEUMOTHORAX IN 4 PATIENTS. ONE PATIENT REQUIRED TUBE THORACOSTOMY.

  Patient problems: Pneumothorax

  MAUDE report 20673892 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE AN ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE PATIENT WAS READMITTED TO THE HOSPIT AL DUE TO A SMALL APICAL PNEUMOTHORAX. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITH THE PNEUMOTHORAX RESOLVED.

  Patient problems: Pneumothorax

  MAUDE report 20662848 ↗
• MalfunctionOct 29, 2024Device Displays Incorrect Message; Communication or Transmission Problem; Device Displays Incorrect Message; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, DURING A ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THERE WAS AN ISSUE WITH THE LOCATION BOARD SIGNAL CUTTING IN AND OUT OF SENSING VOLUME. AFTER GETTING TECHNICAL SERVICES ON THE LINE, IT WAS DETERMINED THAT THERE WAS MOST LIKELY AN ISSUE WITH ONE OF THE CORD CONNECTIONS. THE STAFF THEN TRIED A SECOND SPARE LONG LOCATION BOARD CABLE TO SEE IF THIS WOULD RESOLVE THE ISSUE, IT DID NOT. THEY WERE ABLE TO SUCCESSFULLY FINISH THE CASE THAT THEY HAD ALREADY STARTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558596 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXAMINED 200 CONSECUTIVE PATIENTS REFERRED FOR CONE BEAM CT BRONCHOSCOPIC BIOPSY OF PERIPHERAL LUNG LESIONS BETWEEN APRIL 2021 AND NOVEMBER 2021. THE COMPANY'S CATHETER WERE USED IN THE FIRST 85 PATIENTS AND A COMPETITOR DEVICE WAS USED IN THE NEXT 115 PATIENTS. THE BIOPSY APPROACH INCLUDED AN EXTENDED MULTIMODALITY APPROACH, INCLUDING IN ORDER THE FOLLOWING: FINE NEEDLE ASPIRATE FOR 8 PASSES USING THE COMPANY'S PULMONARY NEEDLE OR A COMPETITOR NEEDLE, CYTOLOGY BRUSH USING THE COMPANY'S CYTOLOGY BRUSH, TRANSBRONCHIAL FORCEPS BIOPSIES WERE PERFORMED USING THE COMPANY'S FORCEPS OR A COMPETITOR DEVICE. POSTOPERATIVE COMPLICATIONS INCLUDED... BLEEDING IN ONE PATIENT. THE PATIENT WITH BLEEDING DEVELOPED POSTOPERATIVE HYPOXEMIA AND REQUIRED OVER-NIGHT HOSPITALIZATION. THE PATIENT ALSO REQUIRED TOPICAL TRAXEMENIC ACID AND TOPICAL EPINEPHRINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19704645 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXAMINED 200 CONSECUTIVE PATIENTS REFERRED FOR CONE BEAM CT BRONCHOSCOPIC BIOPSY OF PERIPHERAL LUNG LESIONS BETWEEN APRIL 2021 AND NOVEMBER 2021. THE COMPANY'S CATHETER WERE USED IN THE FIRST 85 PATIENTS AND A COMPETITOR DEVICE WAS USED IN THE NEXT 115 PATIENTS. THE BIOPSY APPROACH INCLUDED AN EXTENDED MULTIMODALITY APPROACH, INCLUDING IN ORDER THE FOLLOWING: FINE NEEDLE ASPIRATE FOR 8 PASSES USING THE COMPANY'S PULMONARY NEEDLE OR A COMPETITOR NEEDLE, CYTOLOGY BRUSH USING THE COMPANY'S CYTOLOGY BRUSH, TRANSBRONCHIAL FORCEPS BIOPSIES WERE PERFORMED USING THE COMPANY'S FORCEPS OR A COMPETITOR DEVICE. POSTOPERATIVE COMPLICATIONS INCLUDED PNEUMOTHORAX IN THREE PATIENTS. A CHEST TUBE WAS REQUIRED TO TREAT PNEUMOTHORAX IN TWO PATIENTS.

  Patient problems: Pneumothorax

  MAUDE report 19703611 ↗
• MalfunctionJun 17, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SCREEN SHOWED A NAVIGATION CATHETER OUT OF SENSING VOLUME ERROR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554299 ↗
• MalfunctionJun 17, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SCREEN SHOWED A NAVIGATION CATHETER OUT OF SENSING VOLUME ERROR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549439 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall