AVIATORRecalls & reported problems across all models

We found 19 models of AVIATOR by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2016 and Oct 15, 2025 — classified as 3 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (51 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AVIATOR problems

AVIATOR models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AVIATOR 4245020W

  Catheter, angioplasty, peripheral, transluminal
  9 reports
• AVIATOR 4246020W

  Catheter, angioplasty, peripheral, transluminal
  9 reports
• AVIATOR 4244020W

  Catheter, angioplasty, peripheral, transluminal
  8 reports
• AVIATOR 4245030W

  Catheter, angioplasty, peripheral, transluminal
  7 reports
• AVIATOR 4245040W

  Catheter, angioplasty, peripheral, transluminal
  5 reports
• AVIATOR 4246040W

  Catheter, angioplasty, peripheral, transluminal
  5 reports
• AVIATOR 4247020W

  Catheter, angioplasty, peripheral, transluminal
  5 reports
• AVIATOR 4244030W

  Catheter, angioplasty, peripheral, transluminal
  4 reports
• AVIATOR 4244015W

  Catheter, angioplasty, peripheral, transluminal
  3 reports
• AVIATOR 4244520W

  Catheter, angioplasty, peripheral, transluminal
  3 reports
• AVIATOR 4245015W

  Catheter, angioplasty, peripheral, transluminal
  3 reports
• AVIATOR 4246015W

  Catheter, angioplasty, peripheral, transluminal
  3 reports
• AVIATOR 4247015W

  Catheter, angioplasty, peripheral, transluminal
  3 reports
• AVIATOR 4244040W

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• AVIATOR 4245515W

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• AVIATOR 4244515W

  Catheter, angioplasty, peripheral, transluminal
  1 report
• AVIATOR 4244530W

  Catheter, angioplasty, peripheral, transluminal
  1 report
• AVIATOR 4246030W

  Catheter, angioplasty, peripheral, transluminal
  1 report
• AVIATOR 4247040W

  Catheter, angioplasty, peripheral, transluminal
  1 report

Recent AVIATOR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, WHILE FLUSHING THE GUIDEWIRE LUMEN ON A 4MM X 30MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DURING PREPARATION, IT WAS DISCOVERED THAT THE BALLOON WAS ALREADY CRACKED, AND A LEAKAGE OF FLUID WAS COMING FROM THE BALLOON MATERIAL. A NEW 4MM X 30MM CORDIS BALLOON WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING AND NO DIFFICULTY REMOVING STERILE PACKAGING COMPONENTS. THE DEVICE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277986 ↗
• MalfunctionApr 10, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLON OF A 5MM X 40MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 5 ATMOSPHERES (ATM). A 4MM X 40MM AVIATOR PLUS PTA BALLOON CATHETER WAS USED AS A REPLACEMENT AND WAS INFLATED TO 10ATM WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. A CONTRALATERAL APPROACH WAS MADE WITH A 6F NON-CORDIS SHEATH. AN UNKNOWN GUIDEWIRE WAS USED TO CROSS THE LESION PRIOR TO USE OF THE AVIATOR PLUS PTA BALLOON CATHETER. A NON-CORDIS BALLOON CATHETER WAS ALSO USED DURING THIS PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21816179 ↗
• MalfunctionJun 14, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A .014 6.0X40 AVIATOR WAS USED FOR CAROTID ARTERY STENTING (CAS) CASE, BUT THE CALCIFICATION OF THE LESION WAS SO SEVERE THAT THE BALLOON BURST DURING INFLATION. THE DEVICE COULD NOT BE USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537706 ↗
• MalfunctionJun 7, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE .014 4.0X15 AVIATOR PLUS WAS USED. HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR THE DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS IN THE RENAL ARTERY WHICH HAD A 80% STENOSIS. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION WITH MILD VESSEL TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE UNKNOWN GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491918 ↗
• MalfunctionMar 25, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 30MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WHEN INFLATED TO 12 ATMOSPHERES (ATM) AFTER BEING DELIVERED TO THE LESION. AN UNKNOWN BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. AN UNKNOWN PROTECTIVE ¿UMBRELLA¿ WAS PLACED PRIOR TO THE USE OF THE AVIATOR PLUS PTA BALLOON CATHETER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968904 ↗
• InjuryNov 20, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING INFLATION OF A 6MM X 30MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO 13 ATMOSPHERES (ATM), THE DISTAL TIP OF THE BALLOON RUPTURED AND EXTRAVASATED CONTRAST MEDIUM. A 4 X 30 NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT AND DILATED TO 13 ATM. THE PROCEDURE WAS UNEVENTFUL, AND THE EXTRAVASATION HAD IMPROVED ON ITS OWN WITHOUT TREATMENT. THIS WAS DURING A PROCEDURE TO STENT A 75% STENOSED LEFT INTERNAL CAROTID ARTERY LESION WHICH HAD MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE AVIATOR PLUS PTA BALLOON CATHETER WAS BEING USED TO POST-DILATE AN UNKNOWN STENT. THE DEVICE WAS STORED HANDLED AND PREPPED FOR THE INSTRUCTIONS FOR USE AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE DEVICE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY.

  Patient problems: Extravasation

  MAUDE report 18169044 ↗
• MalfunctionAug 28, 2023Leak/Splash; Leak/Splash

  AS REPORTED, THE 4.0X40 .014 AVIATOR PLUS WAS TAKEN OUT OF THE POUCH FOR PRE-PTA. THE THREE-WAY STOPCOCK WAS ATTACHED, AND DEFLATION WAS PERFORMED AS USUAL, BUT THE DEFLATION KEPT GOING INCESSANTLY, SO A RUPTURE OF THE BALLOON OR A LEAK IN THE SHAFT OR HUB WAS EXPECTED, SO THE PRODUCT WAS NOT USED. THE LEAK WAS NOTICED DURING PREP OF THE BALLOON BEFORE USE. WHEN THE AVIATOR PLUS WAS INFLATED OUTSIDE THE PATIENT'S BODY, THE BALLOON EXPANDED, BUT A LOT OF AIR WAS MIXED IN. IT IS UNKNOWN WHERE THE AIR IS COMING FROM, BUT IT SEEMS THAT THE PRODUCT IS DEFECTIVE. THE SAME SIZE BALLOON (NON-CORDIS) WAS USED FOR DILATION, A 10MM STENT WAS IMPLANTED, AND AN AVIATOR 5MM X 3CM WAS USED FOR POST-PTA, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE STENOSIS AT THE CAROTID ARTERY. AN APPROACH WAS MADE FROM THE RIGHT INGUINAL REGION TO THE COMMON CAROTID ARTERY WITH A 8F NON-CORDIS GUIDING CATHETER FOR BACK-UP. A SPIDER PROTECTION GUIDEWIRE WAS INSERTED AND ADVANCED TO THE DISTAL INTERNAL CAROTID ARTERY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630710 ↗
• MalfunctionMar 2, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A .014 5.0X30 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT BACK-FLOW WAS OBSERVED IN THE INDEFLATOR BEFORE THE COMPLAINT DEVICE REACHES THE LESION. THE COMPLAINT DEVICE WAS CHECKED OUTSIDE THE PATIENT AND BALLOON RUPTURE WAS CONFIRMED. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER AVIATOR PLUS AND THE LESION WAS INFLATED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16473385 ↗
• MalfunctionFeb 2, 2023Deflation Problem; Deflation Problem

  AS REPORTED, WHEN THE FILLING BALLOON OF AN AVIATOR PLUS .014 6.0X20 142CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS DEFLATED, IT WAS FOUND TO BE DIFFICULT TO DEFLATE, AND IT TOOK A LONG TIME TO REMOVE IT. THE WITHDRAWAL DIFFICULTY WAS ENCOUNTERED WHEN WITHDRAWING FROM THE GUIDE/SHEATH. ONCE IT WAS REMOVED FROM THE GUIDE IT WAS NOTICED THAT THE DELIVERY ROD WAS KINKED. THERE WAS NO REPORTED PATIENT INJURY. THE AVIATOR PLUS WAS USED BY THE SURGEON TO PRE-EXPAND THE LESION AFTER AN ANGIOGUARD WAS RELEASED INTO PLACE. THE INTENDED PROCEDURE WAS REPORTED TO BE BALLOON DILATION OF THE LEFT INTERNAL CAROTID ARTERY PLUS STENTING. THE LESION CALCIFICATION WAS MODERATE, WITH SEVERE TORTUOSITY AND SEVENTY PER-CENT STENOSIS. THE DEVICE WAS NOT USED FOR A TOTAL CHRONIC OCCLUSION (CTO). THERE WAS NEITHER DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, NOR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY MAINTAINING NEGATIVE PRESSURE. THE SAME INDEFLATOR WAS SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287521 ↗
• MalfunctionFeb 2, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE AVIATOR PLUS DEVICE WAS USED AS PRE-DILATION BUT RUPTURED WITHIN ITS NOMINAL PRESSURE. THE COMPLAINT DEVICE WAS REMOVED, AND THE PROCEDURE COMPLETED. THERE WAS REPORTED INJURY TO THE PATIENT. THE LESION WAS THE SUBCLAVIAN REGION. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286007 ↗
• MalfunctionJan 13, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE AVIATOR PLUS WAS USED. HOWEVER, THE BALLOON RUPTURED AT 8 ATM. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER SAME SIZED AVIATOR PLUS AND ADDITIONAL INFLATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE RENAL ARTERY. AN UNKNOWN GUIDEWIRE WAS INSERTED. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE VESSEL AND NONE NOTED WHILE CROSSING THE LESION. THE LESION HAS MILD CALCIFICATION AND THE VESSEL HAD MILD TORTUOSITY. THE LESION HAD A 90% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158112 ↗
• MalfunctionJun 27, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 4.0MM X 20MM 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS PUNCTURED AND COULD NOT BE INFLATED OR MAINTAIN PRESSURE DURING THE ATTEMPTED INFLATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A CAROTID ARTERY STENTING PROCEDURE. THE DEVICE WAS STORED AND PREPARE PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO KINKS OR DAMAGES OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS N DIFFICULTY CROSSING THE LESION WITH THE AVIATOR PLUS PTA BALLOON CATHETER. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND AND DID NOT KINK DURING ITS USE. AFTER THE BALLOON PUNCTURE WAS OBSERVED, THE BALLOON CATHETER WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. INFORMATION REGARDING THE PATIENT, TARGET LESION CHARACTERISTICS, AND WHETHER THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828400 ↗
• MalfunctionJun 21, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A AVIATOR PLUS .014 6.0X20 RUPTURED. IT WAS REPLACED WITH ANOTHER SAME SIZED UNKNOWN BALLOON CATHETER AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. THE PROCEDURE BEING PERFORMED WAS A BALLOON PULMONARY ANGIOPLASTY (BPA). THE BALLOON DID NOT RUPTURE WHILE IN A STENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE DEVICE ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. THE CATHETER WAS NOTED TO HAVE BEEN IN AN ACUTE BEND; HOWEVER, IT WAS NOTED THE DEVICE WAS NEVER KINKED WHILE BEING USED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753159 ↗
• MalfunctionJun 7, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN AVIATOR PLUS .014 4X20 142CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT THE STENOSIS OF THE INTERNAL CAROTID ARTERY WHEN THE PRESSURE REACHED SEVEN ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED BY USING AN UNKNOWN 4X30 AND 6X 30 CORDIS BALLOON CATHETERS. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS SEVERELY CALCIFIED WITH LITTLE TORTUOSITY. THE LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) WITH A NINETY PERCENT STENOSIS. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE BALLOON FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 1:1. A NON-CORDIS IND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14619832 ↗
• MalfunctionDec 20, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN AVIATOR PLUS .014 5.0X20 142CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST AFTER IT WAS INFLATED SEVERAL TIMES WITHIN THE SPECIFIED PRESSURE. IT WAS REPLACED WITH A NEW UNKNOWN AVIATOR AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS A "BPA" CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046319 ↗

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