SABER 48002525XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032069080), received between Dec 8, 2021 and Sep 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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

• MalfunctionSep 12, 2025Leak/Splash; Leak/Splash

  AS REPORTED, A 2.5MM 25CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DID NOT FULLY INFLATE. IT WAS REMOVED AND REPLACED WITH ANOTHER BALLOON OF THE SAME SIZE. AFTER SURGERY, THE OPERATOR TESTED INFLATION OUTSIDE THE BODY AND OBSERVED LEAKAGE AT ONE LOCATION. THE SURGERY PROCEEDED SMOOTHLY WITHOUT OTHER ADVERSE EFFECTS. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED AFTER STANDARD PROCEDURE AND WETTING, AND AFTER INSERTION INTO THE VESSEL. THE DEVICE WAS USED DURING A LOWER LIMB (BELOW THE KNEE) ARTERY OCCLUSION RECANALIZATION AND BALLOON ANGIOPLASTY. BELOW THE KNEE DILATATION. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING IT FROM THE HOOP, PROTECTIVE BALLOON COVER, OR STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGE WERE NOTED PRIOR TO INSERTION. THE DEVICE WAS PREPPED PER THE IFU AND MAINTAINED NEGATIVE PRESSURE NORMALLY. THE LESION WAS MODERATELY CALCIFIED WITH MILD VESSEL TORTUOSITY AND 70%¿80% STENOSIS. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). NO RESISTANCE OR FRICTION OCCURRED WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER, THOUGH MILD RESISTANCE WAS ENCOUNTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036974 ↗
• MalfunctionSep 1, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER 2.5MM 25CM BALLOON RUPTURED WHEN THE VESSEL WAS DILATED. THE BALLOON RUPTURED AT A PRESSURE CLOSE TO 18 ATM. THE BALLOON WAS THEN WITHDRAWN AND REPLACED BY A BALLOON OF THE SAME MODEL FOR DILATATION, AND THE PROCEDURE WAS COMPLETED. THE PATIENT RETURNED TO THE WARD. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE OPERATION WAS LOWER EXTREMITY PTA STENTING. THE DEVICE WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE 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 DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE MODERATE STENOSIS WITH NO CALCIFICATION. THE VESSEL HAD A LITTLE TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671414 ↗
• MalfunctionDec 8, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING USE, THE SABER 2.5MM X 25CM BALLOON CATHETER AND BALLOON WERE PUNCTURED BY THE WIRE WHEN LOADING IT OVER THE WIRE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS PREPPED PER THE INSTRUCTION FOR USE (IFU) AND 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. FEMORAL RETROGRADE ACCESS WAS MADE. THE BALLOON WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960439 ↗

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