SABER 48003006XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032069325), received between Nov 17, 2020 and Sep 18, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM 6CM .018 SABER PTA CATHETER RUPTURED DURING INFLATION WITHIN NOMINAL PRESSURE. IT IS UNKNOWN WHAT RBP. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE), AND A NEW .018 SABER BALLOON CATHETER WAS OPENED. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORTED INJURY TO THE PATIENT. 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 PEER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE VESSEL WAS NOTED TO HAVE 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. THERE WAS NO DIFFICULTY NOTED WHILE CROSSING THE LESION WITH THE BALLOON. THE DEVICE WAS NEVER IN AN ACUTE BEND. THE SALINE/CONTRAST RATION WAS 50/50. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17767501 ↗
• MalfunctionNov 10, 2021Leak/Splash; Leak/Splash

  AS REPORTED, A 3MM X 6CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ATTEMPTED TO INFLATE; HOWEVER, THE OPERATOR NOTICED LEAKAGE FROM THE BALLOON, AND IT WOULD NOT INFLATE TO ITS NOMINAL PRESSURE. THE BALLOON WAS THEN REMOVED, AND ADDITIONAL BALLOON (UNKNOWN) WAS OPENED TO FINISH THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE SABER WAS OPENED IN A STERILE FIELD AS PER INSTRUCTIONS FOR USE (IFU). THE SABER WAS PREPPED AND INSERTED OVER THE WIRE (UNKNOWN) TO THE TARGET VESSEL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED IN THE FACILITY. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787625 ↗
• MalfunctionJul 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AS THE TIP OF THE 3MM X 6CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS ADVANCED OVER THE GUIDEWIRE (UNKNOWN), THE TIP SEPARATED AND FELL. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE CANNOT BE USED FOR THE PATIENT. THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120022 ↗
• MalfunctionNov 17, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM X 6CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER BURST AT APPROXIMATELY SIX (6) ATMOSPHERES (ATM) UPON INFLATION BEFORE REACHING NOMINAL PRESSURE OF 8 ATMOSPHERES WITH A NON-CORDIS INFLATION DEVICE. THEREFORE, THE BALLOON WAS REMOVED FROM THE PATIENT AND A SECOND UNKNOWN BALLOON WAS USED SUCCESSFULLY. THERE WAS NO HARM AND NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FILED. THE OPERATOR WAS TRAINED TO THE SABER PTA DEVICE. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE ACCESS SITE LOCATION WAS THE FEMORAL ARTERY. THE TARGET SITE HAD CALCIFICATION, NO TORTUOSITY, AND 50% STENOSIS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR 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. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10854659 ↗

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