Pneumatic Inflator M00553200Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729195450), received between Jan 23, 2018 and Aug 21, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (29 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, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50364915 ↗
• MalfunctionAug 12, 2026Display or Visual Feedback Problem; Detachment of Device or Device Component; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229905 ↗
• MalfunctionMay 20, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS ATTEMPTED TO BE USED IN THE CARDIAC REGION DURING AN ESOPHAGEAL DILATION PROCEDURE TO TREAT ESOPHAGEAL ACHALASIA PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS USED FOR A SECOND ACHALASIA DILATION PROCEDURE. IT WAS REPORT THAT AIR WAS BEING INJECTED INTO THE BALLOON; HOWEVER, THE PRESSURE GAUGE DID NOT RISE. IT WAS REPORTED THAT THERE WERE NO ALTERNATIVE PRODUCTS AVAILABLE, THEY PERFORMED THE PROCEDURE UNDER FLUOROSCOPY AND COMPLETED IT WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234089 ↗
• MalfunctionMay 7, 2026Display or Visual Feedback Problem; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC HAND PUMP INFLATION DEVICE WAS ATTEMPTED TO BE USED DURING A BALLOON DILATION PROCEDURE FOR ESOPHAGEAL DILATION IN THE ESOPHAGUS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PRESSURE GAUGE DID NOT FUNCTION PROPERLY. AIR LEAKAGE WAS OBSERVED, RESULTING IN THE INABILITY TO MAINTAIN PRESSURE. CONSEQUENTLY, THE GAUGE READING WAS UNRELIABLE. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119331 ↗
• MalfunctionJan 9, 2026Display or Visual Feedback Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED IN THE LOWER ESOPHAGUS DURING A BALLOON DILATATION PROCEDURE TO TREAT ACHALASIA PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE DEVICE WAS USED, THE GAUGE FAILED TO REACH 20 PSI EVEN WHEN ATTEMPTING TO INFLATE TO THE MAXIMUM PRESSURE OF 20PSI. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF DEVICE GAUGE READING INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024248 ↗
• MalfunctionSep 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PNEUMATIC DILATION PROCEDURE IN THE GASTROESOPHAGEAL JUNCTION PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PNEUMATIC HAND PUMP WAS PREPARED AND CONNECTED FOR BALLOON INSUFFLATION. DURING THE INSUFFLATION STEP, MULTIPLE PUMPING ATTEMPTS WERE MADE HOWEVER, THE MANOMETER DIAL DID NOT REGISTER ANY PRESSURE, AND THE NEEDLE REMAINED AT ZERO THROUGHOUT. DUE TO THE LACK OF PRESSURE INDICATION AND UNCERTAINTY REGARDING BALLOON INFLATION, THE PUMP WAS REMOVED FROM USE TO MITIGATE ANY RISK TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PNEUMATIC INFLATOR AND WITH THE SAME RIGIFLEX DILATATION BALLOON. FOLLOWING THE PROCEDURE, THE DEFECTIVE PNEUMATIC PUMP WAS TESTED. ALL LUER FITTINGS WERE CHECKED FOR TIGHTNESS, AND THE GAUGE WAS LIGHTLY TAPPED TO ASSESS FOR NEEDLE MOVEMENT. NO LEAKS, HISSING SOUNDS, OR BALLOON EXPANSION WERE OBSERVED DURING THIS TESTING. THE GAUGE CONTINUED TO SHOW NO RESPONSE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23184643 ↗
• MalfunctionJan 14, 2025Display or Visual Feedback Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS ATTEMPTED TO BE USED DURING A DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE WAS USED IN AN ATTEMPT TO INFLATE AN ACHALASIA BALLOON. THE BALLOON DID NOT INFLATE, AND DID NOT SHOW ANY PRESSURE CHANGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PNEUMATIC INFLATOR. 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 GAUGE READING INACCURATE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154568 ↗
• MalfunctionJun 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STRICTURE DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO MAINTAIN THE PRESSURE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AS AN ALTERNATIVE DEVICE WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454128 ↗
• MalfunctionApr 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS ATTEMPTED TO BE USED DURING A DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PRESSURE GAUGE IS OFF AND NOT ON ZERO. THE PROCEDURE WAS COMPLETED WITH ANOTHER PNEUMATIC INFLATOR. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072318 ↗
• MalfunctionFeb 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED IN THE ESOPHAGUS DURING AN ACHALASIA DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PUMP INDICATOR REMAINED FIXED EVEN THOUGH THE BALLOON WAS INFLATED. THE CUSTOMER REPORTED THAT THE BALLOON WAS ABLE TO BE INFLATED WITH THE PUMP BUT, THE GAUGE WAS NOT READING ACCURATELY. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELED AS ANOTHER DEVICE WAS NOT AVAILABLE. THE CUSTOMER REPORTED THAT THE PROCEDURE WAS RESCHEDULED AND WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18645856 ↗
• MalfunctionJan 31, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED IN THE GASTROESOPHAGEAL (GE) JUNCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PUMP WAS FUNCTIONAL, BUT THE DIAL DID NOT MOVE. THE CUSTOMER REPORTED THAT THE BALLOON WAS ABLE TO BE INFLATED WITH THE PUMP BUT, THE GAUGE WAS NOT READING ACCURATELY. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615044 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS BEING PREPARED FOR USE IN A GASTROSCOPY PROCEDURE TO BE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE DEVICE WAS NOT FUNCTIONING PROPERLY DUE TO A PUMP LEAK. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELED AS ANOTHER DEVICE WAS NOT AVAILABLE. THE DOCTOR RESCHEDULED THE PROCEDURE TO ANOTHER DAY WITH ANOTHER PNEUMATIC INFLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322162 ↗
• MalfunctionAug 10, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED IN A PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, WHEN INFLATING THE MANOMETER, THE NEEDLE DID NOT GO UP AND DOWN. THE SURGEON PERFORMED THE DILATION BY INCISING ON THE MANOMETER WITHOUT PRECISE MEASUREMENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17501949 ↗
• MalfunctionJul 26, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED IN THE ESOPHAGUS DURING THE DILATION PROCEDURE ON AN UNKNOWN DATE. PRIOR TO THE PROCEDURE, THE PNEUMATIC PUMP WAS NOT CALIBRATED. IT STARTS WITH 30 KPA AND NOT 0. THEY DO NOT FEEL SAFE WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397529 ↗
• MalfunctionJul 28, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MANOMETER OF THE DEVICE WAS NOT WORKING. THE GAUGE MONITOR OF THE DEVICE DID NOT SHOW ANY PRESSURE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD OR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15125206 ↗
• MalfunctionJun 6, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED IN THE ESOPHAGEAL CARDIA DURING A GASTROINTESTINAL DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE GAUGE ALREADY INDICATED THE MAXIMUM VALUE; HOWEVER, IT WOULD NOT INDICATE THE CORRECT PRESSURE BEFORE USE AT THE TIME OF OPENING. INCREASING THE PRESSURE WAS POSSIBLE, AND BASED ON THE JUDGEMENT OF THE PHYSICIAN, ONLY A MINIMAL DILATATION WAS PERFORMED AND COMPLETED THROUGH FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604848 ↗
• MalfunctionMay 25, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED IN THE ESOPHAGUS DURING PNEUMATIC DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT NOTED THAT THE DEVICE DID NOT HAD THE PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PNEUMATIC INFLATOR 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 FINDING OF GAUGE READING INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14493215 ↗
• MalfunctionApr 7, 2022Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR DEVICE WAS USED IN THE CARDIA DURING A GASTROINTESTINAL DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PNEUMATIC PUMP GAUGE STOPPED WORKING AFTER THE SECOND USE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044754 ↗
• MalfunctionOct 18, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PNEUMATIC INFLATORS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PNEUMATIC INFLATORS WERE USED IN THE ESOPHAGUS ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PUMP DOES NOT START AT 0, AND WHEN INFLATED THE PUMP DOES NOT GO ALL THE WAY UP. THE SAME PROBLEM WAS NOTICED ON THE SECOND PNEUMATIC INFLATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER PNEUMATIC INFLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS THE TWO INFLATORS DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652377 ↗
• MalfunctionOct 18, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PNEUMATIC INFLATORS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PNEUMATIC INFLATORS WERE USED IN THE ESOPHAGUS ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PUMP DOES NOT START AT 0, AND WHEN INFLATED THE PUMP DOES NOT GO ALL THE WAY UP. THE SAME PROBLEM WAS NOTICED ON THE SECOND PNEUMATIC INFLATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER PNEUMATIC INFLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652373 ↗
• MalfunctionSep 28, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS UNPACKED FOR A DILATION PROCEDURE TO BE PERFORMED IN THE UPPER ESOPHAGUS ON (B)(6) 2021. DURING THE PREPARATION, THE BALLOON WAS INFLATED; HOWEVER, THE MANOMETER DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH PROGRESSIVE AND CAUTIOUS DILATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540344 ↗
• MalfunctionNov 25, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED DURING AN ACHALASIA DILATION PROCEDURE PERFORMED IN THE GASTRO OESOPHAGEAL JUNCTION (GOJ) ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE INFLATED AND DEFLATED SUCCESSFULLY; HOWEVER, THE NEEDLE OF THE GAUGE WAS STUCK AT ABOUT MID LEVEL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10900434 ↗
• MalfunctionApr 13, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ACHALASIA BALLOON DILATION PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED, THE GAUGE NEEDLE WAS NOT WORKING. REPORTEDLY, THE NEEDLE STAYED AT ZERO AND DID NOT INCREASE, SO THERE WAS NO WAY TO DETERMINE THE ACTUAL INFLATION. THE PROCEDURE WAS COMPLETED WITH THIS 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954156 ↗
• MalfunctionJul 5, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED DURING AN ACHALASIA DILATATION PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE GAUGE NEEDLE OF THE DEVICE WOULD NOT WORK AND STAYED AT 0 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER PNEUMATIC INFLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8765636 ↗
• MalfunctionMay 29, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PRESSURE ON THE GAUGE DOES NOT GO BACK TO ZERO. THERE HAVE BEEN 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 8649913 ↗