SABER 48006006XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032069592), received between Feb 15, 2019 and Feb 3, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 5MM X 40MM 135CM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING A PERIPHERAL PROCEDURE. ADDITIONALLY, A 6MM X 6CM SABER .018 PTA BALLOON CATHETER WAS USED, BUT THE BALLOON RUPTURED IN TWO PIECES. THE DEVICES WERE ABLE TO BE REMOVED EASILY FROM THE PATIENT. AN UNKNOWN SNARING DEVICE WAS USED TO RETRIEVE THE SEPARATED BALLOON, BUT IT WAS NOT SUCCESSFUL. OTHER UNKNOWN BALLOONS WERE USED DURING THIS PROCEDURE. THIS WAS DURING A PROCEDURE TO TREAT A LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH WAS TORTUOUS. THE DEVICES WERE "RESTORED" PROPERLY PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO ISSUES REMOVING THE STERILE PACKAGING. THE DEVICES MAINTAINED NEGATIVE PRESSURE DURING PREPARATION AND WERE PREPPED WITH A 60% CONTRAST AND 40% SALINE MIXTURE. BOTH DEVICES WERE INFLATED TO 8 ATMOSPHERES (ATM). THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292882 ↗
• MalfunctionApr 22, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 6MM 6CM 150 BURST BELOW NOMINAL PRESSURE WHILE IN THE VESSEL. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE BALLOON RUPTURED WHILE IN A STENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS NOTED TO BE CALCIFIED. THE VESSEL DID NOT HAVE ANY TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THE BALLOON WAS FILLED WITH 1/3 OMNIPAQUE CONTRAST AND 2/3 HEPARINIZED SALINE. THE INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE CATHETER ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190929 ↗
• MalfunctionFeb 15, 2019Structural Problem; Structural Problem

  AS REPORTED, THREE SABER 5MM6CM 150, SABER 6MM6CM 150 AND SABER 2.5MM20CM 150 BALLOONS EXPANDED PAST THE MARKER BANDS. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICES WERE RECEIVED BY THE REPRESENTATIVE THE SAME MORNING OF THE PROCEDURE. THE DEVICES WERE STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WERE NO ANOMALIES NOTED TO THE DEVICES WHEN THEY WERE TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGING OR REMOVING THE PRODUCTS FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVERS. THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCTS INTO THE PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANYTIME DURING THE PROCEDURE. THE LESION WAS MODERATELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE BALLOON DID NOT INFLATE NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS NOMINAL. ALL THE MARKER BANDS WERE ACCOUNTED FOR AT THE END OF THE PROCEDURE. THE PATIENT IS DOING FINE. THE TARGET LESION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344668 ↗

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