OptiFlexRecalls & reported problems across all models
Boston Scientific Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of OptiFlex by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2017 and May 12, 2023 — classified as 1 injury, 35 malfunctions.
The most frequently reported specific device problem is “Break” (32 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 OptiFlex problems
Device problems
- Break32
- Difficult to Open or Close10
- Material Deformation8
- Detachment of Device or Device Component3
- Use of Device Problem2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Consequences Or Impact To Patient29
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient2
OptiFlex models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OptiFlex M0063903010DISLODGER, STONE, BASKET, URETERAL, METAL35 reports
- OptiFlex M0063903000DISLODGER, STONE, BASKET, URETERAL, METAL1 report
Recent OptiFlex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTI-FLEX BASKET STERILE POUCH WAS FOUND WITH A FOREIGN MATTER ON APRIL 24, 2023. DURING PREPARATION, IT WAS OBSERVED THAT THERE WAS A DEBRIS IN THE STERILE PACKAGING OF AN OPTI-FLEX BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16918322 ↗InjuryOct 13, 2022Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, A TIP OF THE BASKET BROKE OFF AND HAD TO BE RETRIEVE FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15594478 ↗MalfunctionSep 13, 2021Break; Difficult to Open or Close; Break; Difficult to Open or Close
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE KIDNEY DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THE BASKET FAILED TO OPEN WHEN ATTEMPTING TO CAPTURE THE STONE. WHEN THE BASKET WAS REMOVED FROM THE PATIENT, HANDLE WAS ACTUATED AND FOUND THE BASKET DID OPEN OR CLOSE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12464162 ↗MalfunctionFeb 22, 2021Break; Difficult to Open or Close; Break; Difficult to Open or Close
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. AFTER OPENING THE PACKAGE, THE HANDLE WAS ACTUATED AND FOUND THE BASKET DOES NOT OPEN OR CLOSE. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11362157 ↗MalfunctionFeb 4, 2021Break; Difficult to Open or Close; Material Deformation; Break; Difficult to Open or Close; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE BASKET OPENED INSIDE THE PATIENT BUT FAILED TO CLOSE. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS DETACHED/SEPARATED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11280754 ↗MalfunctionNov 2, 2020Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation; Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS TO BE USED IN THE KIDNEY DURING A FLEXIBLE URETEROSCOPE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BASKET FAILED TO OPEN. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS DETACHED/SEPARATED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10770534 ↗MalfunctionOct 12, 2020Break; Use of Device Problem; Difficult to Open or Close; Material Deformation; Break; Use of Device Problem; Difficult to Open or Close; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10666726 ↗MalfunctionJun 10, 2020Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE LEFT KIDNEY DURING A FIBEROPTIC TRANSURETHRAL LITHOTRIPSY (F-TUL) PROCEDURE PERFORMED ON (B)(6). ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE HANDLE SUDDENLY BECAME HARD AND UNABLE TO MOVE. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10140463 ↗MalfunctionJun 10, 2020Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE OPTIFLEX BASKET WAS TESTED. THE BASKET WAS FOUND TO HAVE OPENED AND CLOSED AT FIRST BUT IT FAILED TO OPEN ON THE SECOND TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLEX BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE PULL WIRE IS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT. PLEASE SEE FOR FULL INVESTIGATION DETAILS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10138275 ↗MalfunctionMar 30, 2020Break; Difficult to Open or Close; Material Deformation; Break; Difficult to Open or Close; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROLITHIASIS PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE WHEEL OF THE BASKET COULD NOT BE ROTATED, AND THE PHYSICIAN'S HAND WAS HURT WHILE ACTUATING AS A RESULT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9900520 ↗MalfunctionMar 2, 2020Break; Use of Device Problem; Material Deformation; Break; Use of Device Problem; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY (F-URS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, PRIOR TO PROCEDURE, THE DEVICE WAS INSPECTED AND FOUND THE BASKET FAILED TO OPEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY STABLE. THE INVESTIGATION FOUND THAT THE PULL WIRE WAS DETACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9774940 ↗MalfunctionJan 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET BECAME UNABLE TO OPEN AND WAS STUCK CLOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLEX BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; PULL WIRE DETACHED/SEPARATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9590828 ↗MalfunctionNov 1, 2019Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. REPORTEDLY, THE HANDLE WOULD NOT MOVE AT ALL. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; PULL WIRE BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9268151 ↗MalfunctionSep 20, 2019Break; Difficult to Open or Close; Material Deformation; Break; Difficult to Open or Close; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE KIDNEY DURING AN RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS, PULL WIRE DETACHED/SEPARATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9100757 ↗MalfunctionJul 26, 2019Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation; Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INVESTIGATION RESULTS REVEALED THAT THE PULL WIRE WAS DETACHED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8831032 ↗
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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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