Saber .035 48007004NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032079881), received between Dec 9, 2024 and Oct 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THREE 7MM X 40MM 80CM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE USED DURING A PROCEDURE. THE FIRST SABER .035 PTA BALLOON CATHETER HAD GREAT DIFFICULTY PASSING OVER A 175CM .035 EMERALD J- TIP GUIDEWIRE AND THE GUIDEWIRE WAS STUCK AT THE HUB. THE PROTECTIVE SHEATH ON THE SECOND SABER .035 PTA BALLOON CATHETER DID NOT COME OFF THE BALLOON AND THE BALLOON WAS DISLODGED FROM THE CATHETER WITH CONSIDERABLE FORCE. THE THIRD SABER .035 BALLOON CATHETER ALSO HAD DIFFICULTY DISLODGING FROM THE BALLOON PORTION AND THERE WAS FRICTION EXPERIENCED DURING PREPARATION. THE RESISTANCE/FRICTION WAS EXPERIENCED BETWEEN THE BALLOON CATHETER AND THE EMERALD GUIDEWIRE, AS IT DID NOT MOVE SMOOTHLY OVER THE CATHETER; THEREFORE, THE DOCTOR DECIDED NOT TO USE THE DEVICE FURTHER IN THE PROCEDURE DUE TO CONCERN IT COULD BECOME STUCK IN THE PATIENT. NONE OF THE THREE DEVICES WERE INSERTED INTO THE PATIENT AND AN UNKNOWN BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A PROCEDURAL DELAY, HOWEVER; THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). REGARDING THE FIRST SABER .035 PTA BALLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323039 ↗
• MalfunctionDec 9, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, TWO .035 7X40 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONS BURST WHILE HAND INFLATION WAS BEING PERFORMED. THE PTA BALLOONS WERE REMOVED AND ADDITIONAL THIRD BALLOON WAS USED AT LESION. THE THIRD BALLOON WAS USED TO FINISH THE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS OPENED AND PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE BALLOONS WERE INSERTED THROUGH THE UNKNOWN SHEATH AND ADVANCED TO THE TARGET LESION. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880257 ↗
• MalfunctionDec 9, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, TWO .035 7X40 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONS BURST WHILE HAND INFLATION WAS BEING PERFORMED. THE PTA BALLOONS WERE REMOVED AND ADDITIONAL THIRD BALLOON WAS USED AT LESION. THE THIRD BALLOON WAS USED TO FINISH THE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS OPENED AND PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE BALLOONS WERE INSERTED THROUGH THE UNKNOWN SHEATH AND ADVANCED TO THE TARGET LESION. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880068 ↗