Encore 26 M00566670Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729755241), received between Jun 20, 2017 and Sep 14, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (16 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 16, 2026.

Recalls naming this device

1. Aug 5, 2025Open, Classified

   The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

   Z-2533-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Display or Visual Feedback Problem

  It was reported to Boston Scientific Corporation that an Encore 26 Inflation Device was being prepared to be used in the Common Bile Duct (CBD) during an Endoscopic retrograde cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During preparation, the gauge barometer failed. The procedure was completed with another Encore 26 Inflation Device.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754002 ↗
• MalfunctionSep 14, 2026Display or Visual Feedback Problem

  It was reported to Boston Scientific Corporation that an Encore 26 Inflation Device was being prepared to be used in the Common Bile Duct (CBD) during an Endoscopic retrograde cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During preparation, the gauge barometer failed. The procedure was completed with another Encore 26 Inflation Device.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748342 ↗
• MalfunctionJul 13, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE BAROMETER MALFUNCTIONED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807882 ↗
• MalfunctionJul 12, 2026Display or Visual Feedback Problem

  It was reported to Boston Scientific Corporation that an Encore 26 inflation device was attempted to be used in the common bile duct during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6)2026.During preparation outside of the patient, the barometer malfunctioned. The procedure was completed with another of the same device. 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 be good.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25790409 ↗
• InjuryMar 26, 2025Display or Visual Feedback Problem; Failure to Deflate; Display or Visual Feedback Problem; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS USED DURING AN ENDOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHILE USING THE INFLATION DEVICE, THE MANOMETER'S NEEDLE DID NOT MOVE, PROVIDING NO INFORMATION ABOUT THE PRESSURE IN THE DILATION BALLOON. THIS LED TO AN OPENING IN THE ESOPHAGUS, WHICH WAS SUBSEQUENTLY TREATED WITH A CLIP. IT WAS ALSO REPORTED THAT WITHDRAWING THE DEVICE WAS DIFFICULT DUE TO INCOMPLETE DEFLATION. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. ***ADDITIONAL INFORMATION RECEIVED ON MARCH 18, 2025***, IT WAS REPORTED THAT THE PROCEDURE DATE WAS ON (B)(6) 2025. IT WAS REPORTED THAT A NON-BOSTON SCIENTIFIC ESOPHAGEAL DILATATION BALLOON WAS USED WITH THE ENCORE 26 INFLATION DEVICE. IT WAS REPORTED THAT THE PATIENT HAD A DEEP HEMORRHAGIC LACERATION OF THE ESOPHAGUS OCCURRED DUE TO EXCESSIVE, UNCONTROLLED PRESSURE. THREE HEMOSTATIC CLIPS WERE PLACED TO CLOSE THE DILACERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Unspecified Tissue Injury

  MAUDE report 21698739 ↗
• MalfunctionSep 17, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENCORE 26 INFLATION DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS ATTEMPTED TO BE USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THAT WAS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE A HURRICANE BALLOON USING THE ENCORE 26 SYRINGE. DURING INFLATION, THE GAUGE OF THE SYRINGE NEVER MOVED AND WAS UNABLE TO EFFECTIVELY DILATE THE BALLOON. A SECOND SYRINGE WAS OPENED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED USING A THIRD ENCORE 26 INFLATION DEVICE FROM A DIFFERENT LOT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241774 ↗
• MalfunctionSep 17, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENCORE 26 INFLATION DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS ATTEMPTED TO BE USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THAT WAS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE A HURRICANE BALLOON USING THE ENCORE 26 SYRINGE. DURING INFLATION, THE GAUGE OF THE SYRINGE NEVER MOVED AND WAS UNABLE TO EFFECTIVELY DILATE THE BALLOON. A SECOND SYRINGE WAS OPENED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED USING A THIRD ENCORE 26 INFLATION DEVICE FROM A DIFFERENT LOT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241672 ↗
• MalfunctionNov 9, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS BEING PREPARED FOR USE IN A PROCEDURE ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTICED THAT THE PACKAGING WAS NOT SEALED CORRECTLY, AND THE STERILITY OF THE DEVICE WAS COMPROMISED. A PHOTO SUBMITTED BY THE CUSTOMER SHOWED THE PACKAGING OF THE DEVICE WAS NOT SEALED CORRECTLY IN PORTIONS AROUND THE PERIMETER OF THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26 INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103631 ↗
• MalfunctionNov 1, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS USED IN THE DUODENUM DURING A DUODENAL BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6)2023. DURING THE PROCEDURE, THE PRESSURE MEMORY OF THE DEVICE WAS NOT WORKING AT ALL. SINCE IT WAS POSSIBLE TO APPLY PRESSURE, THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE WHILE CHECKING THE BALLOON DIAMETER UNDER FLUOROSCOPY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048676 ↗
• MalfunctionJul 12, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS BEING PREPARED FOR USE IN A PROCEDURE ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTICED THAT THERE WERE WRINKLES AT THE PRODUCT OPENING. NO PATIENT COMPLICATIONS WERE 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 17313212 ↗
• MalfunctionMay 12, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS BEING PREPARED FOR USE IN A PROCEDURE ON (B)(6) 2023. UPON OPENING THE DEVICE PACKAGE DURING PREPARATION, A HAIR WAS NOTED INSIDE THE STERILE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER. THE PHOTO SHOWS THE DEVICE OUTSIDE OF THE PATIENT AND A HAIR WAS INSIDE THE STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918755 ↗
• MalfunctionMay 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS BEING PREPARED FOR USE IN A PROCEDURE ON (B)(6) 2023. UPON OPENING THE DEVICE PACKAGE DURING PREPARATION, A HAIR WAS NOTED INSIDE THE STERILE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER. THE PHOTO SHOWS THE DEVICE OUTSIDE OF THE PATIENT AND A HAIR WAS INSIDE THE STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912264 ↗
• MalfunctionJul 21, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE MANOMETER DID NOT WORK AND THE CUSTOMER CONFIRMED THAT THERE WAS NO READING DURING BALLOON INFLATION. THE PROCEDURE WAS COMPLETED WITH AN ALLIANCE SYRINGE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077715 ↗
• MalfunctionJun 6, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS USED IN THE PAPILLA DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE METER DID NOT WORK WELL DURING INFLATION AND THE CUSTOMER CONFIRMED THE GAUGE WAS READING INACCURATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606983 ↗
• MalfunctionJul 10, 2021Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS USED DURING A DILATION OF BRONCHI PROCEDURE PERFORMED ON (B)(6), 2021. DURING UNPACKING, A FLUID WAS NOTICED INSIDE THE PUMPING CATHETER OF THE DEVICE. ADDITIONALLY, THE HANDLE WAS NOT WORKING SMOOTHLY AND THERE WAS RESISTANCE FELT DURING THE HANDLE MOVEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26 INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148082 ↗
• MalfunctionMar 31, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE NEEDLE OF THE PRESSURE GAUGE WAS STUCK AT 4 ATM AND WOULD NOT MOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594942 ↗
• MalfunctionFeb 16, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE NEEDLE OF THE GAUGE DID NOT MOVE WHEN INFLATING THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26 INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335322 ↗
• MalfunctionFeb 15, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS UNPACKED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO BE PERFORMED ON (B)(6) 2021. DURING THE UNPACKING, IT WAS NOTICED THAT THE STERILE PACKAGING WAS NOT SEALED WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11328116 ↗
• MalfunctionOct 20, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE INFLATED SUCESSFULLY; HOWEVER, THE NEEDLE OF THE GAUGE WOULD NOT MOVE AT ALL. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. REPORTEDLY, THE DEVICE WAS SET UP PROPERLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704840 ↗
• MalfunctionSep 21, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE AMPULLA OF VATER ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GAUGE WOULD NOT INDICATE THE CORRECT PRESSURE APPLIED TO THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563694 ↗
• MalfunctionApr 3, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USED IN THE BILIARY DUCT PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER THE BALLOON BURST. REPORTEDLY, IT WAS UNABLE TO BE CONFIRMED IF THE ENCORE INFLATION DEVICE CAUSED THE BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478719 ↗
• MalfunctionFeb 20, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS USED DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED AS OBSERVED ON FLUOROSCOPY; HOWEVER, THE MANOMETER DID NOT MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354476 ↗
• MalfunctionFeb 12, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS USED IN THE BILE DUCT DURING A BILIARY DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A DIRT WAS NOTICED IN THE INNER TUBE OF THE INFLATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332381 ↗
• MalfunctionOct 16, 2017Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS USED IN A PROCEDURE PERFORMED IN THE COLON ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE GAUGE METER WAS DEFECTIVE WHICH CAUSED THE BALLOON TO RUPTURE. THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6952530 ↗
• MalfunctionJun 20, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS OPENED FOR A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, IT WAS NOTED THAT THE DEVICE¿S INNER PLASTIC BLISTER/TRAY WAS BROKEN/CRACKED. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6653980 ↗