MUSTANG™ H74939171060870Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08714729793854), received between Dec 13, 2016 and Dec 2, 2025 — classified as 3 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (34 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 80 MM, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR LESION DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED WITHIN THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND THE PATIENT REMAINED IN EXCELLENT CONDITION THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698193 ↗
• MalfunctionDec 1, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11NOV2025. IT WAS REPORTED THAT DEVICE DIFFICULTY IN ADVANCING OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL VESSEL. A 6.0 X 80, 75CM MUSTANG WAS ADVANCED FOR DILATION. PRIOR TO PROCEDURE, A LOT OF RESISTANCE WERE NOTED WHEN ADVANCING THE SHEATH. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682539 ↗
• MalfunctionOct 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% TARGET LESION WAS LOCATED IN THE BRACHIAL ARTERY, WHICH WAS NON-TORTUOUS AND MILDLY CALCIFIED, WITH NO CHALLENGING ANATOMY REPORTED. A 6.0 X 80; 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE INITIAL INFLATION, THE BALLOON BURST BEFORE REACHING THE NOMINAL BURST PRESSURE (NBP). THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424380 ↗
• MalfunctionOct 24, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30SEP2025. IT WAS REPORTED THAT DIFFICULTY ADVANCING IN THE SHEATH OCCURRED. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING ADVANCING INTO THE SHEATH, IT WAS NOTED THAT THERE WAS A LOT OF RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A TEAR MEASURED 7MM IN LENGTH AND WAS LOCATED IN THE MID REGION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377995 ↗
• MalfunctionAug 18, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS SHUNT. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION, THE BALLOON BURST BEFORE IT REACHED THE NOMINAL BURST PRESSURE (NBP). THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT HAVE A CHALLENGING ANATOMY, AND THE PROCEDURE WAS CARRIED OUT FOLLOWING THE STANDARD PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824928 ↗
• MalfunctionAug 11, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VEIN. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND 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 22769442 ↗
• MalfunctionAug 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). DURING THE PROCEDURE, THE BALLOON RUPTURED IN THE BLOOD VESSEL UPON THIRD INFLATION. 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 22690494 ↗
• MalfunctionJun 30, 2025Entrapment of Device; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON TIP WAS STUCK IN THE STENT STRUT. THE TARGET LESION WAS LOCATED AT THE ARTERIOVENOUS FISTULA (AVF). A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED AFTER SUPERFICIAL FEMORAL ARTERY (SFA) STENTING. HOWEVER, THE BALLOON TIP BECAME STUCK IN THE STENT STRUTS AND THE BALLOON CATHETER COULD NOT CROSS INNOVA IN-STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22362164 ↗
• MalfunctionJun 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION IS LOCATED IN THE SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294536 ↗
• MalfunctionMay 28, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A DIALYSIS PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE AXILLARY ARTERY. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST AND WAS NOTED THE CONTRAST WAS LEAKING. 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 22097255 ↗
• MalfunctionMar 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER BEING INFLATED TWO TO THREE TIMES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING 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 21589880 ↗
• MalfunctionMar 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS (AV) SHUNT. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE IT WAS INFLATED TO RATED BURST PRESSURE (RBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520733 ↗
• MalfunctionFeb 19, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS SHUNT. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE INFLATED TO NOMINAL BURST PRESSURE (NBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT 80% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND SEVERELY MILD ARTERY. THE BALLOON RUPTURED UPON FIRST INFLATION. THE DEVICE WAS REMOVED CAREFULLY AND SLOWLY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417334 ↗
• InjuryJan 21, 2025Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURED, AND THE TIP WAS DETACHED, REQUIRING INTERVENTION. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR TREATING A DIALYSIS GRAFT. DURING THE PROCEDURE, THE BALLOON WAS INFLATED UP TO RATED BURST PRESSURE, BUT IT RUPTURED IMMEDIATELY. UPON REMOVAL, THE DISTAL END OF THE CATHETER MUST HAVE BEEN CAUGHT ON A PLAQUE AND MIGRATED. A SNARE WAS THEN USED TO REMOVE THE FOREIGN BODY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200792 ↗
• MalfunctionDec 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILD CALCIFIED RADIAL ARTERIOVENOUS FISTULA. A 6.0 X 80, 75CM MUSTANG CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST DURING SECOND INFLATION AT 24 ATMOSPHERES UP TO THE RATED BURST PRESSURE (RBP) FOR 30 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20965085 ↗
• MalfunctionSep 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION, THE BALLOON WAS INFLATED 3-4 TIMES. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED AT 18 ATMOSPHERES FOR 2 MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125289 ↗
• MalfunctionAug 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERIOVENOUS FISTULAS. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER 10 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19965195 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED FISTULAGRAM. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BEGAN TO SEPARATE FROM THE SHAFT, PROXIMAL TO THE FIRST RADIOPAQUE (RO) MARKER. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372794 ↗
• MalfunctionMay 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED AFTER THE FIRST INFLATION AT 6TH ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322814 ↗
• MalfunctionApr 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER BEING INFLATED AT 20 ATMOSPHERES FOR 20 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028545 ↗
• MalfunctionSep 27, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-SEP-2023. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN A MILDLY (30') TORTUOUS AND SEVERELY (70') CALCIFIED VESSEL. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT COULD NOT PASS THE ANGLE OF THE LESION DUE TO RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823694 ↗
• MalfunctionSep 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-CALCIFIED ARTERIOVENOUS SHUNT. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS ARTERIOVENOUS SHUNT. THE BALLOON BURST AT 6 BAR DURING INFLATION. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793444 ↗
• MalfunctionSep 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT BRACHIAL ARTERY. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INFLATION AT 22 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789975 ↗
• InjurySep 8, 2023Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON BROKE. AN ATTEMPT WAS MADE TO RECANALIZE AN ARTERIOVENOUS FISTULA (AVF), PRECISELY OF THE CEPHALIC END. A 4MM MUSTANG BALLOON CATHETER WAS USED FOLLOWED BY A 6X80MM MUSTANG BALLOON CATHETER, WHICH BROKE OFF. THERE WAS GREAT DIFFICULTY REMOVING THE BALLOON BECAUSE IT WAS TORN AND RETRACTED. IT WAS IMPOSSIBLE TO REMOVE THROUGH THE NON-BOSTON SCIENTIFIC INTRODUCER. A HEMATOMA APPEARED AT THE ENTRY POINT OF THE INTRODUCER WITH A PIECE OF BALLOON STUCK IN THE VEIN. THE INTRODUCER WAS REMOVED, AND A 9F PROBE WAS PLACED IN CONTACT WITH THE SEVERED BALLOON. AFTER MULTIPLE MANEUVERS, THE ENTIRE BALLOON WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 17715625 ↗
• MalfunctionApr 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NOON-CALCIFIED RADIAL ARTERY. A 6.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT, SLOWLY AND CAREFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776108 ↗