SABER 48003004XRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032069097), received between Aug 1, 2017 and Oct 26, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 3MM4CM 150 RUPTURED IN THE MIDDLE AREA DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS WASHED AND WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12696098 ↗
• MalfunctionMay 27, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 3MM X 4CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT AROUND 12 ATMOSPHERES (ATM) FOR THE SECOND TIME. THE PROCEDURE WAS COMPLETED USING A SAME SIZED NON-CORDIS PTA BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS TO TREAT SEVERE STENOSIS WITH STRONG CALCIFICATION OF THE RIGHT POPLITEAL ARTERY USING A 4.5F 55CM NON-CORDIS SHEATH FOR AN IPSILATERAL FEMORAL APPROACH. TWO NON-CORDIS GUIDEWIRES WERE USED IN COMBINATION TO CROSS THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893335 ↗
• MalfunctionJan 8, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM X 4CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED UNDER THE ECHO GUIDE, HOWEVER, IT RUPTURED ON IT'S THIRD INFLATION. A NON CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH HAD CHRONIC TOTAL OCCLUSION (CTO). THE LESION WAS MODERATELY CALCIFIED AND 100 PERCENT STENOSED. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, 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 PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME UNKNOWN INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, NOR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE BALLOON WAS INFLATED TWICE BEFORE IT RUPTURED. NO UNUSUAL FORCE WAS USED AT ANY TIME DURING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143046 ↗
• MalfunctionJun 22, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE SABER BALLOON 3MM X 4CM X 150CM RUPTURED DURING ENDOVASCULAR PROCEDURES. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION IS UNKNOWN BUT SLIGHTLY CALCIFIED AND TORTUOUS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). 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. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PLUNGER DID NOT DEPRESS INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE THERE WAS NO DIFFICULTY TRACKING TOWARDS THE LESION. THE DEVICE WAS STORED PER THE IFU FOR ONE WEEK. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10179938 ↗
• MalfunctionAug 9, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER (3 MM 4 CM 150) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS INSERTED FOR INFLATION; HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE DURING ITS INITIAL INFLATION. THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER OF THE SAME SIZE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE HAS BEEN DISCARDED IN THE HOSPITAL. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH HAD SEVERE STENOSIS. A CONTRALATERAL APPROACH WAS MADE. THE LESION HAD SEVERE CALCIFICATION. INITIALLY, A MICRO CATHETER AND SUPPORT WIRE (14) CROSSED THE LESION. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE WAS PREP NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). THE ACCESS SITE LOCATION WAS INGUINAL. THERE WAS NO DIFFICULTY 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 INTO THE PATIENT. A NON-CORDIS INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879716 ↗
• MalfunctionJul 9, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER RX PTA BALLOON CATHETER (3MM4CM 150) WAS USED; HOWEVER, IT RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, THE SABER PTA BALLOON WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION AND OCCLUSION. INITIALLY, A CONTRALATERAL APPROACH WAS MADE. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON INFLATED NORMALLY. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE IS NO PROCEDURAL FILM/CD AVAILABLE FOR REVIEW. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISCARDED DUE TO PATIENT¿S SUSPICIOUS INFECTED DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771219 ↗
• MalfunctionJun 1, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER 3MM X 4CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) CROSSED THE LESION AND WAS INFLATED, HOWEVER, IT RUPTURED WITHIN NOMINAL PRESSURE DURING THE THIRD INFLATION AFTER A GUIDEWIRE (14) CROSSED THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS FROM THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE POPLITEAL ARTERY WITH STENOSIS. A CONTRALATERAL APPROACH WAS MADE. THERE WERE NO ANOMALIES DURING DELIVERY BUT THERE WAS MILD CALCIFICATION. THE SABER PTA BC WAS REPLACED WITH A NON-CORDIS SAME SIZED BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THERE WAS A LITTLE CALCIFICATION. THERE WAS NOT ANY VESSEL TORTUOSITY. THERE WAS NOT ANY VESSEL ANGULATION. THE DEVICE WAS NOT BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOT ANY DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NOT ANY DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NOT ANY DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NOT ANY KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8661207 ↗
• MalfunctionMar 28, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER PTA BALLOON CATHETER (3MM4CM 150) WAS USED FOR PRE-DILATION; HOWEVER, IT RUPTURED AT 6-ATMOSPHERE PRESSURE (ATM) WHEN PASSED THE CHRONIC TOTAL OCCLUDED (CTO) LESION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS REPLACED WITH A NON-CORDIS SAME SIZED BALLOON CATHETER. A STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH WAS A TOTAL CHRONIC OCCLUDED (CTO) LESION. THE VESSEL LEVEL OF CALCIFICATION IS SEVERE. THE VESSEL LEVEL OF ANGULATION AND TORTUOSITY IS NONE. INITIALLY, A 6F NON-CORDIS SHEATH AND GUIDE WIRE WAS USED. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO LEAKAGE NOTED FROM THE BALLOON, SHAFT, HUB, OR UNKNOWN SEGMENT. THE CATHETER MIGHT HAVE BEEN TORQUED DURING THE INSERTION TO THE CTO LESION. THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE MIGHT HAVE BEEN SOME UNUSUAL FORCE USED DURING THE INSERTION TO THE CTO LESION. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE IS NO PROCEDURAL FILM/CD AVA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460691 ↗
• MalfunctionAug 1, 2017Burst Container or Vessel; Physical Resistance; Difficult to Advance; Burst Container or Vessel; Physical Resistance; Difficult to Advance

  IT WAS REPORTED THAT THERE WAS RESISTANCE FELT ADVANCING A SABER BALLOON CATHETER TO THE LESION AND THROUGH THE GUIDING CATHETER. THE SABER BALLOON RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE THE BALLOON CATHETER WAS REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. A CONTRALATERAL APPROACH WAS MADE AND A SABER BALLOON WAS INSERTED FOR BACK-UP, HOWEVER THERE WAS RESISTANCE FELT WHILE ADVANCING TO THE LESION. WHEN IT WAS INFLATED AS A PRE-DILATATION, IT RUPTURED. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL WAS NOT TORTUOUS AND MODERATELY CALCIFIED. THE RATE OF STENOSIS WAS 100 % (CTO). THE DEVICE WAS PREP 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6757448 ↗

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