SABER 48004004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 20705032069851), received between Jan 3, 2017 and Dec 12, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K133843); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4×40MM 90CM SABER OTW .018 PTA DILATATION CATHETER RUPTURED WHILE DILATING A CALCIFIED LESION DURING A SUPERFICIAL FEMORAL ARTERY TREATMENT PERFORMED UNDER BODY-SURFACE ULTRASOUND. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE INVOLVED TREATMENT OF A CALCIFIED LESION UNDER ULTRASOUND GUIDANCE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791053 ↗
• MalfunctionJun 27, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 4CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. AS A RESULT, A NON-CORDIS BALLOON CATHETER WAS USED IN PLACE OF THE 4MM X 4CM 90CM SABER PTA BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SHUNT LESION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO TRACK TOWARD THE LESION AND CROSS THE LESION WITHOUT DIFFICULTY. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND AND DID NOT KINK DURING ITS USE. AFTER THE RUPTURE OCCURRED, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828123 ↗
• MalfunctionApr 23, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 4MM 4CM 90 RUPTURED AT IS NOMINAL PRESSURE DURING USE WHILE IN THE LEFT BRACHIOCEPHALIC ARTERY. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE). THE CASE WAS COMPLETED WITH THE USE OF A NON-CORDIS DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP OR WHILE REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE 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 AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS TO DO PTA IN A SHUNT. THE SHUNT WAS IN THE LEFT BRACHIOCEPHALIC ARTERY. THE LESION HAD MODERATE CALCIFICATION WITH LITTLE VESSEL TORTUOSITY. THE LESION HAD AN 80% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE BALLOON WAS NOT IN A STENT WHEN THE BURST OCCURRED. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE ADVANCING THROUGH THE GUIDE CATHETER. THE BALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191019 ↗
• MalfunctionMar 28, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 4MM 4CM 90 WAS INFLATED AND RUPTURED AT 8ATM DURING A SHUNT CASE. THE CASE WAS COMPLETED WITH A NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934128 ↗
• MalfunctionAug 3, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE DOCTOR CONFIRMED THAT THE BLOOD WAS PULLED OUT AND THE BALLOON OF 4MM X 4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WHEN IT WAS INSERTED AND CROSSED THE LESION. IT WAS INFLATED BUT IT WAS NOT ABLE TO BE INFLATED DURING ITS SIXTH INFLATION WHEN THE PRESSURE EXCEEDS ITS NOMINAL PRESSURE. THEREFORE, IT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED AS IT WAS. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 4F NON-CORDIS SHEATH AND A NON-CORDIS GUIDEWIRE WERE INSERTED FROM THE RIGHT FEMORAL ARTERY AND AN APPROACH WAS MADE. THERE WAS NO INFECTIOUS DISEASE. THE DEVICE WAS BROUGHT IN ON THE DAY 1-2 HOURS PRIOR TO THE PROCEDURE AND STORED IN A CARDBOARD BOX. THE PRODUCT WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENT. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12266619 ↗
• MalfunctionMar 29, 2021Material Rupture; Material Rupture

  DURING A SHUNT CASE, A 4MM X 4CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED AT ITS NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON-CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED IN THE HOSPITAL. THE ACCESS SITE WAS THE RADIAL. THERE WAS NO DIFFICULTY REMOVING THE COMPLAINT BALLOON FROM THE FORMING TUBE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREP NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR ANY DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE MAXIMUM INFLATION PRESSURE WAS 8 ATM. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED AND WAS REMOVED EASILY. ADDITIONAL PROCEDURAL DETAILS,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581445 ↗
• MalfunctionMar 29, 2021Material Rupture; Material Rupture

  AS REPORTED, THE 4MM X 4CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED BUT IT RUPTURED AT 10 ATMOSPHERIC PRESSURE (ATM). IT WAS REPLACED WITH ANOTHER BALLOON CATHETER (NON-CORDIS) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT CASE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED DUE TO INFECTIOUS DISEASE. THE SALES REP CANNOT VISIT THE HOSPITAL BECAUSE OF THE COVID-19. THEREFORE, ADDITIONAL INFORMATION CANNOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581332 ↗
• MalfunctionJun 26, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MM X 4CM X 90CM SABER BALLOON CATHETER WAS INSERTED AND CROSSED THE LESION AND WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS ALREADY RUPTURED AND COULD NOT BE INFLATED. THEREFORE, DEVICE WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND IT COULD BE INFLATED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY. AN APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY. THE LESION WAS CHRONIC TOTAL OCCLUSION (CTO) AND HAD SEVERE CALCIFICATION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE HOSPITAL REGULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203112 ↗
• MalfunctionMar 24, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM X 40MM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED. THEREFORE, THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT AND IT WAS REPLACED WITH A NEW SAME SIZE SABER BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INTENDED TO BE USED FOR A SHUNT PTA CASE. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WERE NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND 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 THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). A NON-CORDIS INDEFLATOR WAS USED IN THE PROCEDURE AND THE SAME INDEFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES. 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 C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9872178 ↗
• MalfunctionFeb 24, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MM 4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED IN CONJUNCTION WITH AN UNKNOWN GUIDEWIRE THAT CROSSED THE LESION, HOWEVER, WHEN THE SABER WAS INSERTED AND INFLATED, IT RUPTURED. IT WAS AT 14 ATMOSPHERIC PRESSURE (ATM) THAT THE FIRST BALLOON BURST WHICH WAS NOT AT ITS NOMINAL PRESSURE. THEREFORE, THE SABER DEVICE WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR VASCULAR ACCESS INTERVENTION THERAPY (VAIVT). THE TARGET VESSEL WAS THE SHUNT FOREARM VEIN. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE DEVICE WAS PREPPED NORMALLY AND PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. A B-BRAUN INFLATION DEVICE WAS USED IN CONJUNCTION WITH THE SABER. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9746962 ↗
• MalfunctionDec 20, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER THE DEVICE CROSSED THE STENOSIS, THE BALLOON OF 4MM 4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED AT 4 ATMOSPHERES (ATM). THERE WAS NO PATIENT INJURY. THE LEAKAGE OF CONTRAST MEDIA WAS CONFIRMED. THERE WAS NO DAMAGE TO THE BALLOON. IT WAS REMOVED FROM THE PATIENT BODY WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS A SHUNT CASE. THE DEVICE WHICH HAS BEEN STORED IN A HYGIENE-MANAGED STORAGE, WAS TAKEN OUT FROM ITS TRAY AND INSPECTED. NO DAMAGE WAS CONFIRMED. THE DEVICE WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE GUIDE WIRE CROSSED THE STENOSIS PART AND THE CONDITION OF THE STENOSIS WAS CONFIRMED BY AN X-RAY MACHINE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9503704 ↗
• MalfunctionDec 17, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN UNKNOWN GUIDEWIRE CROSSED THE LESION AND, AFTER THAT, A 4MM X 4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION BALLOON CATHETER (BC) WAS INSERTED FOR PRE-DILATION. HOWEVER, IT RUPTURED AT 8 ATMOSPHERES (ATM). THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER OF THE SAME SIZE AND THE PROCEDURE WAS CONTINUED. THERE WAS NO INJURY TO THE PATIENT. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS THE EXTERNAL ILIAC ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO). THERE WAS SEVERE CALCIFICATION OF LESION BUT THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT LOOKED NORMAL WHEN IT WAS REMOVED FROM ITS PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE DID PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). A NON-CORDIS INFLATION DEVICE WAS USED (INDEFLATOR/SYRINGE). THE SAME INDEFLATOR WAS USED SUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9485101 ↗
• MalfunctionJul 9, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A SABER BALLOON CATHETER (4MM4CM 90) WAS DELIVERED TO THE LESION AND INFLATED TO 8 ATMOSPHERES (ATMS), HOWEVER, THE BALLOON RUPTURED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND HAS BEEN DISCARDED, SO WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8773203 ↗
• MalfunctionJun 6, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED AT SIX ATMOSPHERE (6 ATMS). DURING PRE-DILATION, THERE WAS NO PATIENT INJURY. THE SABER PTA BC WAS REPLACED WITH A NEW BALLOON CATHETER (NON CORDIS) AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE HAS BEEN DISCARDED DUE TO SUSPICIOUS INFECTIOUS DISEASE AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675488 ↗
• MalfunctionMar 1, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER (4MM 4CM 90) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS DELIVERED TO THE LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND INFLATED, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. NO REPORTED PATIENT INJURY. IT WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS CONTINUED. THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8381796 ↗
• MalfunctionJun 15, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A SABER BALLOON CATHETER RUPTURED AT FIVE ATMOSPHERE (5 ATM). THEREFORE IT WAS REPLACED WITH A NON CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. A GUIDEWIRE (CHEVALIER, FMD) AND A NON CORDIS MICRO CATHETER WERE INSERTED AND AN ATTEMPT WAS MADE TO INFLATE A SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER. HOWEVER IT RUPTURED. THE TARGET LESION WAS THE LEFT POPLITEAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE INFLATED NORMALLY. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644772 ↗
• MalfunctionJan 3, 2017Burst Container or Vessel; Detachment Of Device Component; Burst Container or Vessel; Detachment Of Device Component

  IT WAS REPORTED THAT A SABER PTA 4MM4CM 90 BALLOON RUPTURE AND SEPARATED OUTSIDE THE PATIENT AFTER USE. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE OF THE SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED USING A SABER PTA AND IT COMPLETED WITHOUT ANY ISSUE. AFTER THE PROCEDURE, THE PHYSICIAN INFLATED THE SABER PTA OUTSIDE THE PATIENT¿S BODY TO TEST AT WHICH PRESSURE THE BALLOON BURSTS. THE SABER PTA BURST AT 30 ATM, AND IT WAS RADIAL BURST INSTEAD OF SLIT BURST. MOREOVER THE BALLOON WAS SEPARATED INTO TWO AT THE MIDDLE. SINCE THE PHYSICIAN ASSUMED THAT THE SABER PTA BURSTS LIKE A SLIT, S/HE REQUESTED A FINAL LETTER WITH SOME MICROSCOPIC PHOTOS OF THE CROSS SECTION TO VERIFY WHY AND HOW THIS BURST OCCURRED. THE SALES REP EXPLAINED THAT THE BALLOONS DO NOT RUPTURE RADIALLY WHEN THE APPLIED PRESSURE IS WITHIN ITS RBP PLUS 4 ATM, AND ALSO ALL THE PRODUCTS ARE INSPECTED BEFORE SHIPPING. THE TARGET LESION WAS THE SHUNT. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6217936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133843. One submission often covers many models, so check the product and lot details in each record.

• Z-2235-2021 · Jul 19, 2021 · Terminated
  Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X