SABER 48005004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 20705032068649), received between Dec 23, 2016 and Mar 10, 2023 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 5MM X 4CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE DURING USE IN A SHUNT PTA. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED; THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523580 ↗
• MalfunctionFeb 6, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THERE WAS DIFFICULTY CROSSING A SUBCLAVIAN VEIN LESION WITH A 5MM X 4CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DUE TO SEVERE TORTUOSITY. UPON THE INITIAL INFLATION OF THE DEVICE TO 4 ATMOSPHERES (ATM), THE BALLOON HAD RUPTURED. AS A RESULT, A 5MM X 4CM NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 90% STENOSED SUBCLAVIAN VEIN LESION IN WHICH A NON-CORDIS .018 GUIDEWIRE WAS USED AND WAS ABLE TO CROSS THE LESION. THE LESION HAD SEVERE TORTUOSITY BUT SHOWED NO SIGNS OF CALCIFICATION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. 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 16303429 ↗
• MalfunctionDec 26, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER 5MM 4CM RUPTURED AFTER BEING INFLATED WITHIN ITS NOMINAL PRESSURE. THE SABER DEVICE WAS REPLACED WITH ANOTHER BALLOON CATHETER (NON-CORDIS) AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A VAIVT CASE. 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 16048134 ↗
• MalfunctionMar 21, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 5MM4CM 90 PERCUTANEOUS ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT INFLATE DURING A PTA SHUNT PROCEDURE. THE DEVICE WAS REPLACED WITH A SAME SIZE UNKNOWN BALLOON CATHETER TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. THE DEVICE WAS DELIVERED TO THE LESION, HOWEVER PRESSURE DID NOT RISE AND THE BALLOON DID NOT INFLATE. THE PHYSICIAN IS UNCLEAR IF THERE WAS AN AIR LEAK FROM THE CATHETER SHAFT OR A BALLOON RUPTURE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION. ADDENDUM: PER PRODUCT EVALUATION, RESULTS SHOW THE BALLOON LEAKAGE WAS CAUSED BY A RUPTURE ON THE BALLOON SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841193 ↗
• InjurySep 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5MM X 4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BROKE OFF INSIDE THE PATIENT AND WAS STUCK IN THE PATIENT¿S BILIARY TREE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526690 ↗
• MalfunctionJul 6, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM X 4CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED. HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125749 ↗
• MalfunctionJan 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 5MM X 4CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INFLATED AT THE LESION; HOWEVER, WHEN IT WAS REMOVED FROM THE PATIENT¿S BODY, ITS TIP GOT SEPARATED. THE SEPARATED PART WAS ON THE WIRE (UNKNOWN), SO, IT COULD BE REMOVED WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) CASE. THE LESION HAD NO CALCIFICATION. THE VESSEL HAD NO TORTUOSITY. THE VESSEL ANGULATION WAS SEVERE. THERE WAS 90% NOTED OF STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP.THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THE DEVICE WAS USED IN THE PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123214 ↗
• MalfunctionNov 23, 2020Leak/Splash; Leak/Splash

  AS REPORTED, TWO 5MM X 4CM X 90CM SABER OTW PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED BUT THE PRESSURE WAS NOT ABLE TO RISE. IT WAS REMOVED FROM THE PATIENT AND NOTICED THAT IT HAS A PINHOLE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED FOR A SHUNT PTA CASE. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICES WILL BE RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10884629 ↗
• MalfunctionNov 11, 2020Leak/Splash; Leak/Splash

  AS REPORTED, TWO 5MM X 4CM X 90CM SABER OTW PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE INFLATED BUT THE PRESSURE WAS NOT ABLE TO RISE. IT WAS REMOVED FROM THE PATIENT AND NOTICED THAT IT HAS A PINHOLE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED FOR A SHUNT PTA CASE. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICES WILL BE RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10824240 ↗
• MalfunctionOct 27, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MM X 4CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR POST DILATION; BUT IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD CHRONIC TOTAL OCCLUSION (CTO), MILD TORTUOSITY, AND MODERATE CALCIFICATION. AN IPSILATERAL APPROACH WAS MADE. THERE WERE NO DIFFICULTY NOTED IN THE BALLOON DURING PREP. 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED. 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 WILL NOT BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744639 ↗
• MalfunctionAug 24, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM X 4CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AND WAS INFLATED, BUT THERE WAS RESIDUAL STENOSIS; THE BALLOON RUPTURED AT ITS RATED BURST PRESSURE (RBP) DURING SECOND INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) CASE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443128 ↗
• InjuryNov 13, 2019Burst Container or Vessel; Material Separation; Burst Container or Vessel; Material Separation

  AS REPORTED, THE 5MM 4CM 90 SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) BURST DURING THE PROCEDURE. WHEN THE BALLOON WAS PULLED OUT, A PIECE OF IT WAS FALLING INSIDE OF THE PATIENT. THEREFORE, THE PIECE OF THE BALLOON HAD TO BE REMOVED DURING SURGERY. THE DEVICE WAS USED DURING A PTA PROCEDURE AT THE SUPERFICIAL FEMORAL ARTERY (SFA).

  Patient problems: Foreign Body In Patient

  MAUDE report 9315467 ↗
• MalfunctionSep 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THIS WAS A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE, A SABER PTA 5MM4CM 90 WAS INSERTED AND INFLATED; HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THERE WERE NO REPORTED PATIENT INJURIES. AN UNKNOWN SHEATH (4F 4CM) WAS INSERTED AT THE ACCESS ROUTE AND AN UNKNOWN WIRE (0.018INCH) CROSSED THE LESION. THE SABER WAS REMOVED FROM THE PATIENT AND IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE DOCTOR COMMENTED THAT THIS ISSUE OCCURRED BECAUSE THE LESION HAD SEVERE CALCIFICATION. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICE WAS DISCARDED IN THE HOSPITAL. THERE WERE NO ANOMALIES NOTED TO THE DEVICE PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DOCTOR FLUSHED THE DEVICE AS PER THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9123884 ↗
• MalfunctionAug 23, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A SABER PTA BALLOON CATHETER (5MM4CM 90) WAS USED FOR INFLATION. THE WIRE LUMEN COULD BE FLUSHED WITHOUT ANY ISSUES. HOWEVER, A THREAD LIKE NYLON ABOUT 1-CENTIMETER (CM) CAME OUT WHEN A GUIDE WIRE WAS INSERTED. THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, A WIRE WAS REMOVED AND INSERTED AFTER THE FLUSH. THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. INITIALLY, THE WIRE WAS USED WITH ANOTHER NON-CORDIS BALLOON CATHETER BEFORE THE SABER PTA BALLOON CATHETER WAS USED. THERE WAS NO EVIDENCE OF ANYTHING ATTACHED TO THE WIRE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISCARDED BUT THE THINGS LIKE THREAD WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8927702 ↗
• MalfunctionAug 15, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE OF A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE SABER PTA BALLOON CATHETER (BC) WAS INSERTED FOR INFLATION, HOWEVER, THE SABER BC RUPTURED DUE TO CALCIFICATION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS REPLACED WITH A SABER BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS PREPPED WITH ACCORDANCE TO THE INSTRUCTION FOR USE (IFU). 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED. 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 WILL NOT BE RETURNED FOR ANALYSIS DUE TO SUSPICIOUS INFECTIOUS DISEASE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896367 ↗
• MalfunctionMay 6, 2019Deflation Problem; Deflation Problem

  AS REPORTED, A SABER PTA (5MM4CM 90) BALLOON CATHETER WAS DEFLATED BUT IT DID NOT DEFLATED COMPLETELY. A LEAKAGE OF AIR FROM THE HUB WAS CONFIRMED WHEN IT WAS INFLATED OUTSIDE THE BODY. THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, THE SABER PTA BALLOON CATHETER WAS REPLACED WITH A NEW BALLOON CATHETER (6MM) AND THE PROCEDURE WAS COMPLETED. THIS WAS A POSTERO-ANTERIOR (PA) INFLATION CASE. INITIALLY, A SV GUIDEWIRE WAS INSERTED. THE PRODUCT WILL BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8582107 ↗
• MalfunctionMay 26, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A SABER BALLOON CATHETER RUPTURED AT EIGHT ATMOSPHERE (8 ATM). THEREFORE THE SABER BALLOON WAS REPLACED WITH A NEW SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. A 5F UNKNOWN SHEATH INTRODUCER WAS INSERTED TO THE PATIENT, AND A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THEN A SABER PTA WAS DELIVERED TO THE LESION FOR INFLATION. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6594023 ↗
• MalfunctionJan 20, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SABER PTA 5MM4CM 90 BALLOON WOULD NOT INFLATE BECAUSE A LEAK WAS DETECTED FROM THE JOINT OF ITS HUB AND SHAFT. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW SABER PTA AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN APPLIED PRESSURE TO A SABER PTA BALLOON PRIOR TO USE AND THE BALLOON DID NOT INFLATE. AFTER THREE ATTEMPTS, A LEAKAGE WAS CONFIRMED FROM THE JOINT OF ITS HUB AND ITS SHAFT. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS NOT CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6267418 ↗
• MalfunctionDec 23, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SABER PTA BALLOON WOULD NOT INFLATE. AFTER THREE TIMES OF ATTEMPTS, A LEAKAGE WAS CONFIRMED AT THE JOINT OF THE HUB AND THE SHAFT. THEREFORE IT WAS REPLACED WITH A NEW SABER PTA. THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE SABER WAS INFLATED BY AN INDEFLATOR. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS NOT CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6202164 ↗

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