SABER 48006004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032068748), received between Aug 31, 2017 and Jun 19, 2025 — classified as 1 injury, 8 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. 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.

• MalfunctionJun 19, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MMX 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BROKE AT 8 ATMOSPHERES (ATM) AND THERE WAS A RISK OF LEAVING THE BALLOON IN THE VESSEL. THERE WERE NO REPORTED INJURIES TO THE PATIENT. 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 22292016 ↗
• MalfunctionDec 8, 2020Material Rupture; Material Rupture

  A 6MM X 4CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INSERTED AND INFLATED THE LESION; BUT IT RUPTURED. THEREFORE, THE DEVICE WAS REPLACED WITH A NON-CORDIS DEVICE 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 AS IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971718 ↗
• InjuryOct 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 6MM X 4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER WAS IMPLANTED AND DEPLOYED IN PATIENT, BUT THE BALLOON THEN ¿SNAPPED OFF¿. THE SHAFT HAS BEEN RETRIEVED BUT THE BALLOON WAS LEFT IN PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 10670902 ↗
• MalfunctionApr 1, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE, A 6MM 4CM 90 SABER PTA BALLOON CATHETER RUPTURED DUE TO CALCIFICATION. THEREFORE, THE DEVICE WAS REMOVED EASILY AND INTACT (IN ONE PIECE) FROM THE PATIENT AND REPLACED WITH A NEW SAME SIZED BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION HAD SEVERE CALCIFICATION. THE PERCENTAGE OF STENOSIS WAS 99%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND FROM 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 AS PER THE INSTRUCTION FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME TYPE OF INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THROUGH THE GUIDE CATHETER. THE CATHETER WAS IN AN A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910347 ↗
• MalfunctionApr 1, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER 6MM X 4CM 90 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS DELIVERED TO THE LESION, INFLATED AND IT RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION HAD A LITTLE CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO SUSPICIOUS INFECTIOUS DISEASES. THE VESSEL HAS SLIGHT TORTUOSITY. THERE WAS A LITTLE VESSEL ANGULATION. THE DEVICE WAS BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PRODUCT LOOKED NORMAL WHEN IT WAS REMOVED FROM ITS PACKAGING. 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 THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NOT ANY RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NOT ANY RESISTANCE OR FRICTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8469182 ↗
• MalfunctionMar 28, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MMX4CM 90¿ SABER BALLOON BURST AT TEN ATMOSPHERES (10ATM) IN THE INITIAL INFLATION, DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THIS WAS CONFIRMED BY CONTRAST MEDIA LEAKAGE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS A DIALYSIS SHUNT STENOSIS IN THE BRACHIAL VEIN. FOLLOWING THE BALLOON RUPTURE, THE DEVICE WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER (BC) AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459999 ↗
• MalfunctionJan 23, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MM4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS DELIVERED TO THE LESION AND INFLATED WITHIN ITS NOMINAL PRESSURE. HOWEVER, IT RUPTURED AT 10 ATM. THEREFORE, IT WAS REPLACED WITH A SAME SIZE NEW NON-CORDIS BALLOON CATHETER. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. A CONTRALATERAL APPROACH WAS MADE. THE NEW NON-CORDIS BALLOON CATHETER WAS INFLATED AT 10 ATM. A NON-CORDIS STENT WAS IMPLANTED AND THE SAME NON-CORDIS BALLOON CATHETER WAS INFLATED FOR A POST DILATION. THE PROCEDURE WAS COMPLETED. THE DEVICE HAS BEEN DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270332 ↗
• MalfunctionDec 26, 2017Fracture; Fracture

  DURING PREPARATION, IT WAS REPORTED THAT THE TIP OF THE SABER BALLOON CATHETER WAS FRACTURED. THE SABER BALLOON WAS REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT PTA. THE LESION WAS THE SHUNT. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY WAS UNKNOWN. THE LESION WAS NOT CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7146967 ↗
• MalfunctionAug 31, 2017Leak/Splash; Leak/Splash

  DURING THE PREPARATION OF A SABER BALLOON CATHETER, ACCORDING TO THE INSTRUCTION FOR USE (IFU), IT WAS NOT POSSIBLE TO INDUCE NEGATIVE PRESSURE. AS A CONSEQUENCE, THE BALLOON WAS NOT USED FOR THE PROCEDURE. A NEW SABER BALLOON WAS CHOSEN FOR THE PROCEDURE AND WAS USED SUCCESSFULLY ON THE PATIENT. THERE WAS NO PATIENT INJURY AS THE BALLOON WAS NOT IN THE PATIENT. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR ANY DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS ALSO NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE CONTRAST MEDIA USED WAS (B)(6) AND THE CONTRAST TO SALINE RATIO WAS 1:1. THE INFLATION DEVICE WAS A SYRINGE. THE PRODUCT WILL BE SENT IN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836040 ↗

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