SABER 48005004XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032069530), received between Jan 22, 2020 and Mar 14, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 5MM 4CM RUPTURED BELOW RBP WHILE INFLATING IN THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE ANY DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET/STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE CALCIFICATION WITH NO VESSEL TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THE NON-CORDIS INFLATION DEVICE WAS FILLED WITH A ¼ CONTRAST ¾ SALINE MIXTURE. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THE CASE. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE BALLOON CATHETER ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE BALLOON CATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760723 ↗
• MalfunctionApr 22, 2020Burst Container or Vessel; Burst Container or Vessel

  THE 5MM X 4CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD CROSS THE LESION HOWEVER IT RUPTURED AT ITS NOMINAL PRESSURE AND IT WAS REMOVED FROM THE PATIENT¿S BODY. THEREFORE, THE SABER BALLOON CATHETER WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE SABER BALLOON CATHETER WAS ATTEMPTED TO BE USED FOR PRE- PLAIN OLD BALLOON ANGIOPLASTY (POBA) FOR AN ENDOVASCULAR THERAPY (EVT) PROCEDURE. THE DEVICE WAS PREPPED WITHOUT ANY ISSUES AND WILL NOT BE RETURNED FOR ANALYSIS SINCE IT WAS DISCARDED DUE TO SUSPICIOUS INFECTIOUS DISEASES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989019 ↗
• MalfunctionMar 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A PIECE OF THE TIP OF A 5MM 4CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS BROKEN OFF. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON WAS NOT INSERTED INTO THE PATIENT. SINCE THE DEFECT WAS DETECTED DURING PREPARATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE WAS DEVICE PREPPED PER THE IFU. THE CATHETER WAS NOT RE-SHAPED BY THE USER. THE PHYSICIAN NOTICED ANOMALY THAT THE TIP WAS BROKEN DURING PREPARATION. THERE WAS NO CONTACT WITH THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW BALLOON. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862983 ↗
• MalfunctionJan 22, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5 MM X 4 CM X 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED HOWEVER, IT RUPTURED WITHIN ITS NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING A NON-CORDIS BALLOON CATHETER AND HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR 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. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THIS WAS ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH SEVERE CALCIFICATION, MODERATE TORTUOSITY WITH 99% STENOSI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617023 ↗

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