SABER 48004020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032069493), received between Oct 3, 2019 and Feb 10, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 20CM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED. ANOTHER SABER .018 PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS 50/50. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343008 ↗
• MalfunctionSep 19, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE BALLOON OF A 4MM X 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO HOLD PRESSURE. AFTER REMOVING THE DEVICE, THE DEVICE WAS FLUSHED, AND THE BALLOON WAS FOUND TO HAVE A PIN HOLE IN IT. A NEW 4MM X 15CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITHOUT ANY DIFFICULTY IN REMOVING THE STERILE PACKAGING COMPONENTS. DURING PREPARATION, THE DEVICE SUCCESSFULLY MAINTAINED NEGATIVE PRESSURE. THE TARGET VESSEL FOR THE PROCEDURE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE CHARACTERISTICS OF THE TARGET SITE VESSEL INCLUDED SEVERE CALCIFICATION, WITH NO TORTUOSITY, AND A STENOSIS PERCENTAGE OF 75%. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256833 ↗
• MalfunctionFeb 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A PLASTIC PORTION OF THE BALLOON OF A 4MM X20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER BROKE OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RECEIVED FOR ANALYSIS AND THE PRODUCT EVALUATION REVEALED A SEPARATED DISTAL TIP IN ADDITION TO A CRACKED HUB. THE USER IS TRAINED TO THE DEVICE. THE PRODUCT WAS PROPERLY STORED AND OPENED IN STERILE FIELD. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420023 ↗
• MalfunctionOct 21, 2021Difficult to Remove; Difficult to Remove

  A 4MM20CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED TO TREAT THE INFERIOR GENICULAR (POPLITEAL) ARTERY BUT "AFTER THE BALLOON WAS OPENED, IT COULD NOT BE FULLY RETRACTED, AND THE BLOOD VESSEL WAS DIRECTLY WITHDRAWN WITHOUT SECONDARY EXPANSION." THE DEVICE WAS USED INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673372 ↗
• MalfunctionOct 15, 2021Deflation Problem; Deflation Problem

  AS REPORTED, THE FILLING AND DEFLATING SPEED OF THE BALLOON OF A 4MM X 20CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS SIGNIFICANTLY SLOWER. THERE WAS NO REPORTED PATIENT INJURY. THE PERCENTAGE OF STENOSIS WAS 80%. THE CONTRAST TO SALINE RATION WAS 1:1. THE MAXIMUM INFLATION PRESSURE WAS 10ATM. IT TOOK 2 MINUTES TO INFLATE THE BALLOON AND 2 MINUTES TO DEFLATE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638834 ↗
• MalfunctionOct 3, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER 4MM20CM 150 BALLOON WAS USED TO EXPAND THE LESION IN THE TREATMENT OF THE LOWER EXTREMITY ARTERIAL OCCLUSIVE DISEASE, THE BALLOON WAS RUPTURED AT TEN ATMOSPHERES. THE PATIENT WAS UNHARMED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS STORED IN THE CATH LAB FOR TWO WEEKS. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE 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. CONTRAST IOPAMIDOL WAS USED AND THE CONTRAST TO SALINE RATIO WAS 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON CATHETER WAS REMOVED EASILY AND INTACT. THE TARGET LESION WAS ANTERIOR TIBIAL ARTERY. THE LESION WAS CALCIFIED. THERE WAS NO VESSEL TORTUOSITY AND THERE WAS ONE HUNDRED PERCENT STENOSIS. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152528 ↗

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