CRE Fixed Wire M00558370Recalls & reported problems

Summary

The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 08714729195993), received between Jun 2, 2017 and Sep 21, 2026 — classified as 5 injuries, 214 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (121 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 219 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Failure to Deflate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846422 ↗
• MalfunctionAug 25, 2026Difficult to Remove; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was attempted to be used in the esophagus during a Gastrointestinal Dilation procedure performed on (b)(6) 2026.During device removal following the completion of the procedure, the deflated balloon catheter became lodged at the distal end of the endoscope working channel and could not be withdrawn through the channel. The procedure was completed by removing the endoscope and balloon together. Subsequent bench testing was unable to remove the balloon from the endoscope. Upon inspection, the distal tip was bent and twisted. The procedure was completed with the original device. There were no patient complications reported as a result of this event and the patient condition following procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50425855 ↗
• MalfunctionAug 21, 2026Difficult to Remove; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50376412 ↗
• MalfunctionAug 14, 2026Burst Container or Vessel; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246792 ↗
• MalfunctionJul 7, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS BEING PREPARED TO BE USED DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE BALLOON CATHETER WAS NOTICED TO BE BROKE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738453 ↗
• MalfunctionJul 7, 2026Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS INTENDED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT UPON RECEIPT, THE PACKAGE WAS FOUND ALREADY OPEN. THERE WAS NO EVIDENCE OF PACKAGING DAMAGE BEYOND THE COMPROMISED SEAL. 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 25736800 ↗
• MalfunctionMay 25, 2026Use of Device Problem; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS PUSHED THROUGH THE SCOPE AND INFLATED. UPON ATTEMPTING TO DEFLATE THE BALLOON, IT DID NOT DEFLATE PROPERLY. THE PROCEDURE WAS STILL COMPLETED WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE PRE-INFLATED PRIOR TO USE IN THE PROCEDURE. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS PRE-INFLATED OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271378 ↗
• MalfunctionMay 8, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS BEING INFLATED TO A DIAMETER OF 18 MM, AND THE BALLOON POPPING WAS FELT, FOLLOWED BY IMMEDIATE DEFLATION OF THE BALLOON. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125865 ↗
• MalfunctionMay 1, 2026Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE POPPED AND HAD TWO DIFFERENT SMALL HOLES WHERE WATER WAS LEAKING. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059611 ↗
• MalfunctionApr 8, 2026Difficult to Remove; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS STUCK AND COULD NOT BE REMOVED OUT THE SCOPE. IN ADDITION, THE BALLOON WAS UNABLE TO COMPLETELY DEFLATE. 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 24821036 ↗
• MalfunctionMar 23, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR ESOPHAGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON POPPED WHILE INFLATING. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665882 ↗
• MalfunctionFeb 6, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE IT REACHED THE FIRST ATM REQUIRED FOR THE DILATION, AND NO RESISTANCE WAS FELT DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283318 ↗
• MalfunctionJan 29, 2026Difficult to Remove; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AND DILATION WAS PERFORMED SATISFACTORILY. HOWEVER, THE BALLOON DID NOT FULLY DEFLATE AND COULD NOT BE WITHDRAWN THROUGH THE ENDOSCOPE. THE BALLOON CATHETER WAS CUT TO ALLOW REMOVAL OF THE BALLOON FROM THE ENDOSCOPE. THE PROCEDURE WAS THEN COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206831 ↗
• MalfunctionJan 27, 2026Inflation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE FOR TREATMENT OF A STRICTURE PERFORMED ON (B)(6) 2025 DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE ALONG ITS FULL 8 MM LENGTH. ONLY A PORTION OF THE BALLOON EXPANDED, RESULTING IN PARTIAL INFLATION AND LOCALIZED OVER DILATION OF THE INFLATED SECTION. THE BALLOON ALSO DID NOT REACH THE REQUIRED DIAMETER ALONG ITS FULL LENGTH, CREATING AN UNEVEN INFLATION SHAPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULL RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189280 ↗
• MalfunctionDec 30, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A 15,18 MM BALLOON BURST WHEN INFLATED TO 18 MM. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 23931468 ↗
• MalfunctionDec 30, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A 15,18 MM BALLOON BURST WHEN INFLATED TO 18 MM. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 23931467 ↗
• MalfunctionDec 3, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BALLOON RUPTURED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704452 ↗
• MalfunctionNov 12, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON DID NOT FULLY DEFLATE AFTER DILATING THE ESOPHAGUS. THE CATHETER COULD NOT BE REMOVED SO THE SCOPE WAS WITHDRAWN FROM THE PATIENT, AND THE BALLOON END WAS CUT OFF TO BE REMOVED FROM THE SCOPE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 12, 2025. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538802 ↗
• MalfunctionNov 5, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON DID NOT FULLY DEFLATE AND HAD DIFFICULTY REMOVING THE BALLOON FROM THE SCOPE. THE STAFF HAD TO CUT THE CATHETER TO REMOVE THE BALLOON FROM THE SCOPE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473177 ↗
• MalfunctionOct 27, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING WITHDRAWAL, THE BALLOON DOES NOT COME OUT OF THE SCOPE AS THEY SHOULD AFTER INFLATION. IT WAS REPORTED THAT THE BALLOON WAS NOT ABLE TO BE FULLY DEFLATED BEFORE REMOVING FROM THE PATIENT AND HAD TO CUT THE BALLOON AT THE TIP OF THE SCOPE TO REMOVE THE BALLOON. 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 23398826 ↗
• MalfunctionOct 15, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST WHEN ATTEMPTING TO ACHIEVE MAXIMUM DIAMETER OF 18MM. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302806 ↗
• MalfunctionAug 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT THERE WAS A HOLE IN THE BALLOON. THE TYPE OF PROCEDURE AND ANATOMY LOCATION OF THE PROCEDURE ARE UNKNOWN AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. 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 22924110 ↗
• MalfunctionAug 8, 2025Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE TO TREAT GASTROINTESTINAL STENOSIS PERFORMED ON (B)(6) 2025. DURING INFLATION, THE PRESSURE INCREASED NORMALLY UP TO 5 ATM. HOWEVER, IT FAILED TO RISE FURTHER, AND THE BALLOON DID NOT EXPAND. A PINHOLE LEAK WAS SUSPECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22760883 ↗
• MalfunctionJul 25, 2025Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO THE ONE OF TWO CRE FIXED WIRE DILATATION BALLOON DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON BURST AT 16.5 MM AFTER THE SECOND DEFLATION. A SECOND CRE FIXED WIRE DILATATION BALLOON WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610352 ↗
• MalfunctionJul 25, 2025Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO THE ONE OF TWO CRE FIXED WIRE DILATATION BALLOON DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON BURST AT 16.5 MM AFTER THE SECOND DEFLATION. A SECOND CRE FIXED WIRE DILATATION BALLOON WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610344 ↗