SABER 48008002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20705032068885), received between Jan 20, 2017 and Sep 16, 2020 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MM X 2CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER RUPTURED. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER UNKNOWN BALLOON CATHETER AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THE PRODUCT LOOKED NORMAL WHEN IT WAS REMOVED FROM ITS PACKAGING. THE DEVICE PREPPED NORMALLY. 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 INTO THE PATIENT. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THE DEVICE DID NOT HAVE TO PASS THROUGH A PREVIOUSLY PLACED STENT. THE BALLOON WAS INFLATED ONCE PRIOR TO THE BURST. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THERE WERE NO OTHER ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS DISCARDED BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540567 ↗
• MalfunctionMar 3, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN 8MM X 2CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AND FLUSHED OUTSIDE THE PATIENT AND IT WAS NOTICED THAT THE CONTRAST MEDIA WAS LEAKED. IT WAS CONFIRMED THAT THE SABER BALLOON WAS RUPTURED. THEREFORE, THE DEVICE WAS REPLACED WITH THE SAME SIZE SABER BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9783007 ↗
• MalfunctionDec 13, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 8 MM 2 CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED BUT IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9466728 ↗
• MalfunctionJul 25, 2019Leak/Splash; Leak/Splash

  AS REPORTED, AN 8MM X 2CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED FOR INFLATION OF THE LESION. IT INFLATED AT NEGATIVE PRESSURE WHEN IT WAS PREPPED. HOWEVER, THE AIR CAME OUT WHEN IT INFLATED AT NEGATIVE PRESSURE. THE DOCTOR STOPPED USING IT. THERE WAS NO PATIENT INJURY REPORTED. THIS WAS A PEDIATRIC PERCUTANEOUS TRANSLUMINAL AORTIC VALVULOPLASTY (PTAV) CASE. THE PATIENT DID NOT HAVE AN INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829190 ↗
• MalfunctionFeb 21, 2019Leak/Splash; Leak/Splash

  AS REPORTED, THIS WAS A PEDIATRIC CASE, A SABER 8MM2CM 90 PTA WAS PREPPED PRIOR TO USE, IT WAS DEFLATED WITH AN INDEFLATOR; HOWEVER, AIR LEAKAGE WAS CONFIRMED. THERE WERE NO REPORTED PATIENT INJURIES. THE PHYSICIAN TRIED SEVERAL TIMES, BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN SUSPECTED THAT THE HUB HAD MALFUNCTION OR BALLOON RUPTURE. THEREFORE, THE SABER WAS REPLACED WITH A NEW SABER 7.0*20. THE PROCEDURE WAS COMPLETED WITH A NEW 5FR SHEATH AND A NON-CORDIS BALLOON CATHETER. NONE OF THESE DEVICES USED TO COMPLETE THE PROCEDURE HAD AIR LEAKAGE WITH THE SAME INDEFLATOR. THE SABER WAS STORED ON A SHELF WITH OTHER DEVICES. THE PRODUCT WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. IT WAS UNCLEAR WHICH COMPONENT OF THE DEVICE HAD THE LEAKAGE. THE DEVICE WAS NEVER USED INSIDE OF THE PATIENT BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357446 ↗
• MalfunctionFeb 5, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING PREPARATION, FOR AN ENDOVASCULAR TREATMENT (EVT) CASE, TWO SABER PTA 8MM2CM BALLOONS WERE INFLATED BEFORE THEY WERE INSERTED INTO THE PATIENT; HOWEVER, BALLOON RUPTURE WAS CONFIRMED BY LEAKING OF CONTRAST MEDIA. THERE WERE NO REPORTED PATIENT INJURIES. A NEW BALLOON CATHETER WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE STORED ON A SHELF WITH OTHER DEVICES. THE DEVICES WERE STORED, HANDLED AND PREPPED PER THE INSTRUCTION FOR USE (IFU). THE DEVICES WERE PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOPS OR REMOVING THE PROTECTIVE BALLOON COVERS. THERE WAS NO DIFFICULTY REMOVING THE STYLETS OR ANY OF THE STERILE PACKAGING COMPONENTS. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8305539 ↗
• MalfunctionFeb 5, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING PREPARATION, FOR AN ENDOVASCULAR TREATMENT (EVT) CASE, TWO SABER PTA 8MM2CM BALLOONS WERE INFLATED BEFORE THEY WERE INSERTED INTO THE PATIENT; HOWEVER, BALLOON RUPTURE WAS CONFIRMED BY LEAKING OF CONTRAST MEDIA. THERE WERE NO REPORTED PATIENT INJURIES. A NEW BALLOON CATHETER WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE STORED ON A SHELF WITH OTHER DEVICES. THE DEVICES WERE STORED, HANDLED AND PREPPED PER THE INSTRUCTION FOR USE (IFU). THE DEVICES WERE PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOPS OR REMOVING THE PROTECTIVE BALLOON COVERS. THERE WAS NO DIFFICULTY REMOVING THE STYLETS OR ANY OF THE STERILE PACKAGING COMPONENTS. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8305534 ↗
• MalfunctionJan 2, 2019Leak/Splash; Leak/Splash

  DURING PREP OF AN ENDOVASCULAR CASE, A SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER HAD A PINHOLE AS THERE WAS ANOMALY FELT DURING AIR PURGE OUTSIDE THE PATIENT. THERE WAS NO PATIENT INJURY. THEREFORE THE SABER PTA WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8208128 ↗
• MalfunctionMay 18, 2018Leak/Splash; Leak/Splash

  DURING A "PPI" CASE, IT WAS REPORTED THAT THE SABER BALLOON CATHETER WAS CONFIRMED TO BE RUPTURED DURING AIR PURGE WHILE PREP OF THE DEVICE. THERE WAS NO PATIENT INJURY. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICE WAS NOT INSERTED IN THE PATIENT. THERE WERE NO DIFFICULTY INFLATING 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 INFLATION DEVICE WAS USED. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7525537 ↗
• MalfunctionNov 22, 2017Deflation Problem; Deflation Problem

  DURING PREPERATION, IT WAS REPORTED THAT THERE WAS DIFFICULTY DEFLATING THE SABER BALLOON CATHETER (BC). THEREFORE SABER BALLOON WAS REPLACED WITH ANOTHER SABER BALLOON CATHETER, HOWEVER THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BUT IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THIS CASE OCCURRED IN PEDIATRICS. DURING THE PREPARATION OF A SABER BC, THE AIR FROM THE BALLOON COULD NOT BE REMOVED COMPLETELY AFTER SEVERAL TIMES OF ATTEMPT AND IT COULD NOT COMPLETE AIR PURGE. THEREFORE IT WAS REPLACED WITH ANOTHER SABER BC, HOWEVER THE SAME ISSUE OCCURRED. THE TARGET LESION WAS THE PULMONARY ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCTS WERE NOT CLINICALLY USED AND THEY WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052351 ↗
• MalfunctionNov 22, 2017Deflation Problem; Deflation Problem

  DURING PREPARATION, IT WAS REPORTED THAT THERE WAS DIFFICULTY DEFLATING THE SABER BALLOON CATHETER (BC). THEREFORE SABER BALLOON WAS REPLACED WITH ANOTHER SABER BALLOON CATHETER, HOWEVER THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BUT IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THIS CASE OCCURRED IN PEDIATRICS. DURING THE PREPARATION OF A SABER BC, THE AIR FROM THE BALLOON COULD NOT BE REMOVED COMPLETELY AFTER SEVERAL TIMES OF ATTEMPT AND IT COULD NOT COMPLETE AIR PURGE. THEREFORE IT WAS REPLACED WITH ANOTHER SABER BC, HOWEVER THE SAME ISSUE OCCURRED. THE TARGET LESION WAS THE PULMONARY ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCTS WERE NOT CLINICALLY USED AND THEY WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052203 ↗
• MalfunctionJan 20, 2017Leak/Splash; Leak/Splash

  DURING PREP, IT WAS REPORTED THAT THE SABER 8MM2CM 90 BALLOON COULD NOT DEFLATE, THE AIR WAS NOT REMOVED SUFFICIENTLY SINCE THE AIR PERSISTENTLY RELEASED. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW SABER PTA AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6267362 ↗

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