CellebrityRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 4 models of Cellebrity by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Jul 5, 2017 and Aug 27, 2026 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 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
Reports received per month, all models
Most reported Cellebrity problems
Device problems
- Detachment of Device or Device Component22
- Mechanical Problem14
- Break4
- Bent2
- Detachment Of Device Component2
- Material Split, Cut or Torn2
- Retraction Problem1
- Unsealed Device Packaging1
Patient problems
- No Consequences Or Impact To Patient22
- No Clinical Signs, Symptoms or Conditions8
- Hemorrhage/Blood Loss/Bleeding2
- Perforation2
- Pneumothorax2
- No Known Impact Or Consequence To Patient1
Cellebrity models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cellebrity M00516150BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)17 reports
- Cellebrity M00516010BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)10 reports
- Cellebrity M00516070BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)3 reports
- Cellebrity M00516000BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 reports
Recent Cellebrity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Unsealed Device Packaging
It was reported to Boston Scientific Corporation that a Cellebrity was to be used during an Esophagogastroduodenoscopy (EGD) procedure performed on (b)(6) 2026.During preparation, the device was opened and the seal was missing from the packaging. The procedure was completed with another device of the same model. There were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484060 ↗MalfunctionSep 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED IN A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THEY PULLED THE BRUSH OUT OF THE SCOPE THE INTERNAL WIRE STAYED IN THE SCOPE AND THE PATIENT. A PHOTO OF THE DEVICE WAS PROVIDED SHOWING THE WORKING LENGTH DETACHED. THE BRUSH WAS REMOVED BY PULLING THE WIRE STICKING OUT OF THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23125996 ↗MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO PULMONARY CYTOLOGY BRUSHES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PULMONARY CYTOLOGY BRUSH WAS TO BE USED DURING A PULMONARY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A CYTOLOGY BRUSH WAS OPERATED, AND IT WAS OBSERVED THAT THERE WAS NO BRUSH ATTACHED TO THE METAL TIP. ANOTHER BRUSH WAS OPENED FROM THE SAME LOT, WHICH ALSO DID NOT HAVE A BRUSH ATTACHED ON THE METAL TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER PULMONARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501803 ↗MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO PULMONARY CYTOLOGY BRUSHES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PULMONARY CYTOLOGY BRUSH WAS TO BE USED DURING A PULMONARY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A CYTOLOGY BRUSH WAS OPERATED, AND IT WAS OBSERVED THAT THERE WAS NO BRUSH ATTACHED TO THE METAL TIP. ANOTHER BRUSH WAS OPENED FROM THE SAME LOT, WHICH ALSO DID NOT HAVE A BRUSH ATTACHED ON THE METAL TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER PULMONARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501801 ↗MalfunctionJan 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SHEATH PULLED OFF THE WIRE AND BRUSH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON JANUARY 21, 2025*** THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21266145 ↗MalfunctionSep 20, 2024Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY PULMONARY CYTOLOGY BRUSH WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE BROKE WITHIN THE CATHETER NEAR THE BRUSH PORTION. THE BRUSH DID NOT COMPLETELY DETACH. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268699 ↗MalfunctionAug 22, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY BRUSH WAS USED DURING A ROBOTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. BEFORE THE DEVICE COULD BE USED, THE BRUSH WOULD NOT DEPLOY. THE YELLOW TUBING WAS BROKEN OFF. THE PROCEDURE WAS REPORTED TO BE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031739 ↗InjuryAug 22, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04035 FOR THE FIRST CELLEBRITY BIOPSY BRUSH AND 3005099803-2024-03937 FOR THE SECOND CELLEBRITY BIOPSY BRUSH. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY BRUSH WAS USED DURING A ROBOTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN DEPLOYING THE BRUSH, THE SHEATH BROKE OFF AT THE HANDLE AND WENT FORWARD INTO THE PATIENT, PUNCTURING THE LUNG. THE PATIENT EXPERIENCED BLEEDING AND A PNEUMOTHORAX. COLD SALINE WAS APPLIED, AND A CHEST TUBE WAS PLACED. A SECOND BRUSH WAS USED AND BROKE WHEN THE BRUSH WAS PUT ON THE MICROSCOPE SLIDE. THE PROCEDURE WAS REPORTED TO BE COMPLETED. THE PATIENT WAS HOSPITALIZED BEYOND THE STANDARD OF CARE DUE TO THIS EVENT AND WAS REPORTED TO HAVE FULLY RECOVERED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 20, 2024. IT WAS REPORTED THAT THE SECOND CELLEBRITY USED FAILED TO EXTEND THE BRUSH PRIOR TO BEING USED IN THE PROCEDURE. A THIRD BRUSH WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Perforation; Pneumothorax
MAUDE report 20025161 ↗InjuryAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04035 FOR THE FIRST CELLEBRITY BIOPSY BRUSH AND 3005099803-2024-03937 FOR THE SECOND CELLEBRITY BIOPSY BRUSH. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY BRUSH WAS USED DURING A ROBOTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN DEPLOYING THE BRUSH, THE SHEATH BROKE OFF AT THE HANDLE AND WENT FORWARD INTO THE PATIENT, PUNCTURING THE LUNG. THE PATIENT EXPERIENCED BLEEDING AND A PNEUMOTHORAX. COLD SALINE WAS APPLIED, AND A CHEST TUBE WAS PLACED. A SECOND BRUSH WAS USED AND BROKE WHEN THE BRUSH WAS PUT ON THE MICROSCOPE SLIDE. THE PROCEDURE WAS REPORTED TO BE COMPLETED. THE PATIENT WAS HOSPITALIZED BEYOND THE STANDARD OF CARE DUE TO THIS EVENT AND WAS REPORTED TO HAVE FULLY RECOVERED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 20, 2024. IT WAS REPORTED THAT THE SECOND CELLEBRITY USED FAILED TO EXTEND THE BRUSH PRIOR TO BEING USED IN THE PROCEDURE. A THIRD BRUSH WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Pneumothorax
MAUDE report 20023761 ↗MalfunctionJul 22, 2020Mechanical Problem; Retraction Problem; Detachment of Device or Device Component; Mechanical Problem; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CELLEBRITY CYTOLOGY BRUSHES WERE PREPARED FOR USE PRIOR TO DIAGNOSING THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE AND OUTSIDE THE PATIENT, THEY SAID THAT THE BRUSHES WERE NOT EXTENDING OR RETRACTING CORRECTLY. THEY CAME THIS WAY OUT OF THE BOX AND NEITHER ONE OF THEM WERE USED ON ANY PATIENTS. REPORTEDLY, NO VISIBLE ISSUES WERE NOTED WITH THE HANDLES OF THESE BRUSHES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE WORKING LENGTH (SHEATH) WAS DETACHED FROM THE HANDLE. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE INVESTIGATION RESULTS WHICH REVEALED THAT THE YELLOW SHEATHING WAS DETACHED AT THE HANDLE, IT WAS DETERMINED THAT THE MEDICAL DEVICE REPORT (MDR) WAS SENT IN ERROR. DETACHMENT OF THE SHEA
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10310482 ↗MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10295193 ↗MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10295178 ↗MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10295173 ↗MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10295171 ↗MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10295147 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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