SENSATION Short Throw M00562670Recalls & reported problems
Boston Scientific Corporation · Single-Use Polypectomy Snare · Class 2
All models of SENSATION Short Throw (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Boston Scientific Sensation snare is a single-use wire loop used to remove growths during colonoscopy. Many of the 178 reports describe the snare failing to tighten or cut polyps during colonoscopy. The reports include 165 malfunctions, 13 injuries and no deaths. Reports from the last 12 months number 11, compared with 2 in the 12 months before. One recall, started in January 2021 and still open, concerns packaging with an incomplete seal.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 178
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 08714729748083), received between Feb 1, 2017 and Jun 15, 2026 — classified as 13 injuries, 165 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (154 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jan 19, 2021Class IIOpen, Classified
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Z-1170-2021 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Cut154
- Entrapment of Device35
- Retraction Problem30
- Failure to Deliver Energy25
- Electrical /Electronic Property Problem12
- Difficult to Open or Close10
- Defective Device9
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- No Consequences Or Impact To Patient58
- Tissue Damage12
- No Known Impact Or Consequence To Patient11
- Hemorrhage/Blood Loss/Bleeding9
- Hematoma3
- Foreign Body In Patient1
- Tissue Breakdown1
Recent adverse event reports
The 25 most recent of 178 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2026Retraction Problem; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO CLOSE AND TO CUT THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512811 ↗MalfunctionJun 15, 2026Retraction Problem; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SENSATION SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO CLOSE AND TO CUT THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25505789 ↗MalfunctionJun 15, 2026Retraction Problem; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SENSATION SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO CLOSE AND TO CUT THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25505763 ↗MalfunctionJun 4, 2026Retraction Problem; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SENSATION SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE PRESENTED RETRACTION PROBLEMS AND FAILED TO FULLY CLEAN CUT THROUGH TISSUE AND PRESENTED RETRACTION ISSUES. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391402 ↗MalfunctionJun 4, 2026Retraction Problem; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SENSATION SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE PRESENTED RETRACTION PROBLEMS AND FAILED TO FULLY CLEAN CUT THROUGH TISSUE AND PRESENTED RETRACTION ISSUES. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391401 ↗MalfunctionJun 4, 2026Retraction Problem; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SENSATION SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE PRESENTED RETRACTION PROBLEMS AND FAILED TO FULLY CLEAN CUT THROUGH TISSUE AND PRESENTED RETRACTION ISSUES. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391400 ↗MalfunctionMay 18, 2026Failure to Deliver Energy
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SENSATION SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO DELIVERY ENERGY. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25205192 ↗MalfunctionApr 21, 2026Retraction Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE DEVICE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SNARE WOULD NEVER TIGHTEN UP. THEY ENDED UP HAVING TO PULL THIS SNARE OFF THE POLYP AND GET ANOTHER ONE AROUND IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF THE CAUTERY PIN DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941994 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. IT WAS REPORTED THAT THE SNARE WIRE BROKE WHILE ATTEMPTING TO RESECT A POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865606 ↗MalfunctionApr 10, 2026Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARES WAS USED IN AN UNKNOWN PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. IT WAS REPORTED THAT THE PRODUCT IS NOT FUNCTIONING PROPERLY, AS THE PHYSICIAN IS REQUIRED TO HEAT THE DEVICE TO ENABLE PROPER OPERATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843910 ↗MalfunctionNov 13, 2025Entrapment of Device; Failure to Cut; Difficult to Open or Close; Entrapment of Device; Failure to Cut; Difficult to Open or Close
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SENSATION SHORT THROW SNARE WAS USED TO REMOVE A LARGE COLORECTAL SESSILE POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WOULD NOT COAGULATE THE POLYP, AND THE SNARE BECAME STUCK. IT WAS NECESSARY TO CUT THE SNARE AND ATTEMPT RETRIEVAL OF THE POLYP AND SNARE MANUALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23548073 ↗InjuryFeb 6, 2025Entrapment of Device; Mechanical Problem; Failure to Cut; Entrapment of Device; Mechanical Problem; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WAS UNABLE TO OPEN, THUS IT WAS UNABLE TO COMPLETELY CUT THROUGH THE POLYP. THE SNARE WAS STUCK AROUND A PEDUNCULATED POLYP, AND THEY WERE UNABLE TO REMOVE IT DURING THE CASE. THE PATIENT HAD TO BE SENT TO THE HOSPITAL. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 21322853 ↗InjuryNov 18, 2024Entrapment of Device; Entrapment of Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED FOR A POLYP ON (B)(6) 2024. DURING THE PROCEDURE, THE SNARE BECAME STUCK IN A SEMI-OPEN POSITION. THE TECHNICIAN ATTEMPTED TO OPEN AND CLOSE IT MULTIPLE TIMES BUT WAS UNSUCCESSFUL. THE PROVIDER COULD NOT REMOVE THE SNARE FROM AROUND THE TISSUE AND HAD TO CUT THE LOOP TO TAKE THE SNARE OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION MEDIUM OVAL FLEXIBLE SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706950 ↗MalfunctionJun 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW WAS USED IN A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE COULD NOT CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SHORT THROW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19611049 ↗MalfunctionMar 11, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE SNAPPED AND THE WIRE INSIDE THE SHEATH WAS ALL BENT. THE SNARE WAS SUCCESSFULLY LOOPED AROUND THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MARCH 13,2024. THE PROCEDURE PERFORMED WAS COLONOSCOPY. THE PROCEDURE WAS PERFORMED ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18880356 ↗MalfunctionFeb 22, 2024Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) , 2023. DURING THE PROCEDURE, THE DEVICE WAS PASSED THROUGH THE SCOPE AND WAS OPENED AND CLOSED A FEW TIMES, BUT THE DEVICE WOULD NOT CUT THROUGH THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18764219 ↗MalfunctionOct 12, 2023Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut
NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # (B)(4) FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE LOOP WAS PLACED AROUND THE POLYP WHICH WAS SMALLER THAN 27MM IN SIZE, HOWEVER THE LOOP WOULD NOT CLOSE AROUND THE POLYP. AS A RESULT, THE POLYP COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17919888 ↗MalfunctionOct 12, 2023Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut
NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-05377 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE LOOP WAS PLACED AROUND THE POLYP WHICH WAS SMALLER THAN 27MM IN SIZE, HOWEVER THE LOOP WOULD NOT CLOSE AROUND THE POLYP. AS A RESULT, THE POLYP COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17919883 ↗MalfunctionOct 3, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARES WERE NOT CUTTING AS EFFECTIVELY AS THEY SHOULD BE. IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862041 ↗MalfunctionOct 3, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARES WERE NOT CUTTING AS EFFECTIVELY AS THEY SHOULD BE. IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862024 ↗MalfunctionOct 3, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE.. DURING THE PROCEDURE, THE SNARES WERE NOT CUTTING AS EFFECTIVELY AS THEY SHOULD BE. IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861889 ↗InjuryAug 22, 2023Entrapment of Device; Failure to Cut; Entrapment of Device; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THREE DIFFERENT PHYSICIANS FROM THREE SEPARATE PROCEDURES WERE ATTEMPTING TO REMOVE A LARGE POLYP WITH A SNARE, BUT ENCOUNTERED DIFFICULTIES. THE SNARE BECAME STUCK WHILE TRYING TO CUT THROUGH THE POLYP, MAKING IT IMPOSSIBLE TO CAUTERIZE IT. DESPITE THEIR EFFORTS, THEY WERE UNABLE TO REMOVE THE SNARE AND HAD TO RESORT TO CUTTING OFF THE PLASTIC SHEATH USING PLIERS AND THEN UTILIZED A 15MM CAPTIVATOR II SNARE TO REMOVE THE REMAINING PARTS OF THE POLYP IN SMALL PIECES, DISLODGING THE ORIGINAL SNARE. THIS OCCURRED WITH TWO SEPARATE BATCHES OF THE SAME SNARE. THE PROCEDURE WAS COMPLETED WITH A CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17599603 ↗InjuryAug 18, 2023Entrapment of Device; Failure to Cut; Entrapment of Device; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THREE DIFFERENT PHYSICIANS FROM THREE SEPARATE PROCEDURES WERE ATTEMPTING TO REMOVE A LARGE POLYP WITH A SNARE, BUT ENCOUNTERED DIFFICULTIES. THE SNARE BECAME STUCK WHILE TRYING TO CUT THROUGH THE POLYP, MAKING IT IMPOSSIBLE TO CAUTERIZE IT. DESPITE THEIR EFFORTS, THEY WERE UNABLE TO REMOVE THE SNARE AND HAD TO RESORT TO CUTTING OFF THE PLASTIC SHEATH USING PLIERS AND THEN UTILIZED A 15MM CAPTIVATOR II SNARE TO REMOVE THE REMAINING PARTS OF THE POLYP IN SMALL PIECES, DISLODGING THE ORIGINAL SNARE. THIS OCCURRED WITH TWO SEPARATE BATCHES OF THE SAME SNARE. THE PROCEDURE WAS COMPLETED WITH A CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17577521 ↗InjuryAug 18, 2023Entrapment of Device; Failure to Cut; Entrapment of Device; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THREE DIFFERENT PHYSICIANS FROM THREE SEPARATE PROCEDURES WERE ATTEMPTING TO REMOVE A LARGE POLYP WITH A SNARE, BUT ENCOUNTERED DIFFICULTIES. THE SNARE BECAME STUCK WHILE TRYING TO CUT THROUGH THE POLYP, MAKING IT IMPOSSIBLE TO CAUTERIZE IT. DESPITE THEIR EFFORTS, THEY WERE UNABLE TO REMOVE THE SNARE AND HAD TO RESORT TO CUTTING OFF THE PLASTIC SHEATH USING PLIERS AND THEN UTILIZED A 15MM CAPTIVATOR II SNARE TO REMOVE THE REMAINING PARTS OF THE POLYP IN SMALL PIECES, DISLODGING THE ORIGINAL SNARE. THIS OCCURRED WITH TWO SEPARATE BATCHES OF THE SAME SNARE. THE PROCEDURE WAS COMPLETED WITH A CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17577517 ↗MalfunctionJul 17, 2023Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE 27MM SNARE DID NOT FUNCTION AS INTENDED. IT DID NOT ACTIVATE OR ENABLE THE UTILIZATION OF A HIGH CURRENT FOR THE PURPOSE OF CUTTING POLYP. AFTER TESTING THE DEVICE AGAIN USING A DIFFERENT ERBE GENERATOR, IT FUNCTIONED CORRECTLY. IT WAS OBSERVED THAT THE TECHNICIAN MAY NOT HAVE CONNECTED THE SNARE PROPERLY TO THE CORD. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17336789 ↗
Other SNARE, FLEXIBLE devices
- CAPTIFLEX M00562400Boston Scientific Corporation · SNARE, FLEXIBLE3 recalls85 reports
- SENSATION Short Throw M00562650Boston Scientific Corporation · SNARE, FLEXIBLE1 recall173 reports
- Ultratome XL M00535900Boston Scientific Corporation · SNARE, FLEXIBLE205 reports
- CAPTIVATOR M00562340Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls71 reports
- CAPTIVATOR II M00561230Boston Scientific Corporation · SNARE, FLEXIBLE1 recall83 reports
- CAPTIVATOR M00562320Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls32 reports
- CAPTIVATOR M00562300Boston Scientific Corporation · SNARE, FLEXIBLE1 recall78 reports
- Ultratome XL M00535920Boston Scientific Corporation · SNARE, FLEXIBLE122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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