Emerge™ H7493918912250Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 08714729806103), received between Sep 19, 2018 and Nov 24, 2025 — classified as 4 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (28 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 24, 2019Class IITerminated

   Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

   Z-0577-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Material Separation; Device Markings/Labelling Problem; Material Separation; Device Markings/Labelling Problem

  IT WAS REPORTED THAT IMPROPER LABELLING OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR USE. FOLLOWING INFLATION OF THE BALLOON, THE 12 MM BALLOON WAS NOTICED TO HAVE EXTENDED WELL BEYOND THE MARKER BANDS, INDICATING THAT AN INCORRECT BALLOON LENGTH HAD BEEN LABELED ON THE BOX. IT WAS ALSO REPORTED THERE WAS A DEVICE DETACHMENT, BUT NO FURTHER DETAILS WERE PROVIDED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED WITH MODERATE CALCIFICATION. PREVIOUSLY IT WAS REPORTED THAT THERE WAS A DEVICE DETACHMENT BUT NOW IT IS REPORTED THERE WAS NO DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639458 ↗
• MalfunctionOct 28, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED WITHIN A HEAVILY CALCIFIED SEGMENT. A 2.50 MM X 12 MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404550 ↗
• InjuryMay 22, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE MIDDLE SHAFT WAS FRACTURED. THE DETACHED PORTION WAS COMPLETELY REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071617 ↗
• MalfunctionApr 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50MM X 12MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT STENOSIS WAS 80% OF THE TARGET LESION AND LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS INFLATED ONCE AND BURST DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857278 ↗
• MalfunctionFeb 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN AND ANTERIOR ST-ELEVATION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. ANGIOGRAPHY REVEALED SEVERELY CALCIFIC CORONARY DISEASE WITH A 99% MID LEFT ANTERIOR DESCENDING ARTERY (LAD) STENOSIS WITH TIMI 2 FLOW AND A 99% PROXIMAL LARGE DIAGONAL STENOSIS. A 2.50MM X 12MM EMERGE BALLOON WAS UNABLE TO DILATE THE LAD AT 20 ATMOSPHERES (ATM) BECAUSE OF THE HEAVY CALCIFICATION AND THE BALLOON RUPTURED. A CUTTING BALLOON WAS THEN SELECTED BUT WOULD NOT CROSS THE LESION. A 2.00MM X 12MM NC EMERGE BALLOON WAS SELECTED TO DILATE THE DIAGONAL AND THAT BALLOON RUPTURED AT 12 ATM. A LOCAL DISSECTION IN THE DIAGONAL WAS ALSO NOTED AND A NON-BOSTON SCIENTIFIC (BSC) BALLOON WAS SELECTED TO SUCCESSFULLY DILATE THE LESIONS AT 12-14 ATM. THE LAD WAS THEN STENTED WITH A 2.25 MM X 20 MM SYNERGY DRUG ELUTING STENT AT 18 ATM AND THE DIAGONAL STENTED WITH A 2.25 MM X 12 MM SYNERGY STENT AT 16 ATM. A NON-BSC GUIDE EXTENSION CATHETER WAS USED TO ASSIST IN THE BALLOON AND STENT PLACEMENTS AND THE END RESULT WAS EXCELLENT. THIS WAS A BIFURCATION OR V STENT AND THE LAD STENT HAD TO BE REDILATED AFTER STENTING THE DIAG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472452 ↗
• MalfunctionNov 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT RATED BURST PRESSURE, THE BALLOON BURST. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784431 ↗
• InjuryJul 23, 2024Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK HAD OCCURRED, NECESSITATING ADDITIONAL INTERVENTION. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE DISTAL BALLOON CATHETER WAS BROKEN INSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED BY SNARE, AND NO COMPLICATIONS WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811585 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE 30-40CM FROM THE HUB JUST OUTSIDE THE HEMOSTASIS VALVE. SUBSEQUENTLY, ANOTHER 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED, BUT THE SHAFT ALSO BROKE NEAR THE HUB. BOTH DEVICES WERE PULLED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375391 ↗
• InjuryFeb 23, 2024Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTIES OCCURRED, REQUIRING SURGERY. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS 70% STENOSED, SEVERELY TORTUOUS, AND MODERATELY CALCIFIED. AFTER TWO STENTS WERE DEPLOYED SEPARATELY AT THE BIFURCATION, SITUATED FROM THE LEFT MAIN INTO THE LEFT ANTERIOR DESCENDING ARTERY AND LEFT CIRCUMFLEX, A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED TO CROSS THE SIDE BRANCH THROUGH A STENT STRUT. HOWEVER, THE SHAFT BROKE 9 CM FROM THE DISTAL TIP AND WAS LEFT DISTAL THROUGH THE STENT STRUT. A SNARE WAS ADVANCED, BUT DUE TO TORTUOSITY COUPLED WITH THE STENT STRUTS, RETRIEVAL OF THE DEVICE WAS EXTREMELY DIFFICULT. THE PATIENT REMAINED IN STABLE CONDITION WITH NO ABNORMALITIES IN PRESSURE DESPITE THE BALLOON BEING STUCK. AFTER CONSIDERING CATHETER-BASED OPTIONS FOR RETRIEVAL, THE PHYSICIAN DECIDED TO SEND THE PATIENT TO OPEN HEART SURGERY TO EXTRACT THE BALLOON BEFORE THE PATIENT BECAME UNSTABLE. THE FRACTURED DEVICE WAS REMOVED IN OPEN HEART SURGERY WITH NO DAMAGE OBSERVED ON THE IMPLANTED STENT, AND THE PROCEDURE WAS COMPLETED. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769226 ↗
• MalfunctionFeb 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664493 ↗
• MalfunctionOct 20, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND NON-TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY EXTENDING INTO THE FIRST OBTUSE MARGINAL BRANCH. THERE WAS ANGULATION INTO THE LCX. AFTER A SAMURAI GUIDE WIRE, ALONG WITH ANOTHER WIRE, WAS PLACED, A 2.50 MM X 12 MM EMERGE BALLOON CATHETER WAS ADVANCED ON THE SAMURAI. WHEN THE BALLOON WAS IN THE GUIDE CATHETER, IT GOT STUCK ON THE SAMURAI WIRE. IT WAS NOTED THAT THE WIRES WERE NOT CROSSED BUT THE BALLOON GOT STUCK MIDWAY IN THE GUIDE. THE EMERGE BALLOON AND SAMURAI WIRE REMAINED INTACT AND WERE REMOVED TOGETHER. THERE WAS NO VISIBLE DAMAGE TO THE EMERGE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980651 ↗
• MalfunctionSep 21, 2023Break; Material Puncture/Hole; Break; Material Puncture/Hole

  IT WAS REPORTED THAT A SHAFT HOLE AND SHAFT BREAK OCCURRED. A 2.50MM X 12MM FG EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INSERTION OF THE DEVICE, THE SHAFT FRACTURED AND A HOLE WAS NOTED AT THE END OF THE BALLOON SHAFT. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17792581 ↗
• MalfunctionJul 22, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 2.50MM X 12MM EMERGE BALLOON CATHETER, IT WAS NOTICED THAT THE HYPO TUBE PORTION OF THE BALLOON WAS NOT STRAIGHT AND LOOKED ALMOST LINE AN "S". IT WAS ALSO NOTICED THAT THERE WAS A FRACTURE ON THE SHAFT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375505 ↗
• MalfunctionJun 29, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND HEAVILY CALCIFIED MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, RESISTANCE WAS NOTICED DURING DELIVERY OF THE DEVICE, AND THE SHAFT OF THE BALLOON FRACTURED. THE DEVICE WAS REMOVED WITH THE CATHETER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232308 ↗
• MalfunctionNov 4, 2022Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. UPON OPENING A 2.50MM X 12MM EMERGE BALLOON CATHETER, THE BALLOON POCKET WAS FOUND TO BE DAMAGED, AND THE PRODUCT WAS CONTAMINATED. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726426 ↗
• MalfunctionAug 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325514 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE INSERTING PRIOR TO CROSS THE LESION, THE BALLOON WAS NOTED TO BE BROKEN THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A NEW 2.5X12MM EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255016 ↗
• InjuryJun 28, 2022Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE 2.50MM X 12MM EMERGE BALLOON WAS INTRODUCED BUT BECAME LODGED IN THE LESION. THE DEVICE COULD NOT BE ADVANCED AND WHEN REMOVAL WAS ATTEMPTED, THE SHAFT BROKE. THE FRACTURED BALLOON SHAFT WAS SNARED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847064 ↗
• MalfunctionMay 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. DURING UNPACKING OF A 2.50MM X 12MM EMERGE BALLOON CATHETER, THE BALLOON TIP WAS BENT AND THE DEVICE WAS NOTED TO BE FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550617 ↗
• MalfunctionMar 22, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE TRYING TO CROSS THE LESION, THE SHAFT BROKE NEAR THE LEVEL OF THE TOUHY OUTSIDE THE PATIENT'S BODY. THE REMAINING PROXIMAL SHAFT WAS REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13845734 ↗
• MalfunctionJan 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 11 ATMOSPHERES FOR 8 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.5 X 12 NC EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281004 ↗
• MalfunctionDec 7, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHAFT BROKE UPON GOING IN TO THE TOUHY. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957931 ↗
• MalfunctionNov 2, 2021Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND DURING INFLATION, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739607 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE MID PART OF THE SHAFT BROKE. ANOTHER 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED; HOWEVER, THE SHAFT ALSO BROKE. BOTH DEVICES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319229 ↗
• MalfunctionApr 27, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED CIRCUMFLEX ARTERY. FOLLOWING PRE DILATATION WITH A 2.50MM X 12MM EMERGE BALLOON CATHETER, AN UNKNOWN STENT WAS INTRODUCED BUT IT COULD NOT BE ADVANCED AND WAS REMOVED. THE EMERGE BALLOON WAS RE-INSERTED AND AS IT WAS BEING ADVANCED, THE SHAFT BROKE AT THE DISTAL END PROXIMAL TO THE BALLOON PORTION. THE BALLOON WAS REMOVED SAFELY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735624 ↗