SABER 48004004XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032069448), received between Aug 15, 2019 and Nov 26, 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 18, 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.

• MalfunctionNov 26, 2025Crack; Crack

  AS REPORTED, A LONG CRACK WAS FOUND ON ONE SIDE OF THE 4MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THE PROCEDURE WAS COMPLETED USING ATHERECTOMY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS PROPERLY STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS O DAMAGE NOTED TO THE PACKAGING AND NO DIFFICULTIES ENCOUNTERED DURING UNPACKING. THERE WERE NO ISSUES REMOVING THE PRODUCT FROM THE HOOP, THE BALLOON COVER, OR ANY STERILE COMPONENTS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656063 ↗
• MalfunctionSep 18, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MM X 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON BURST BELOW RATED BURST PRESSURE (RBP) DURING INFLATION. THE PROCEDURE WAS COMPLETED USING A NON-CORDIS DEVICE THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A SUPERFICIAL FEMORAL ARTERY (SFA) SHUNT PTA PROCEDURE. THE LESION WAS NOT CALCIFIED, VESSEL TORTUOSITY WAS SEVERE, AND THE PERCENTAGE OF STENOSIS WAS 90%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PRODUCT WAS STORED AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, AND NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND, AND THE BALLOON CATHETER DID NOT KINK DURING USE. THE CONTRAST TO SALINE RATIO WAS 1:1. THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084600 ↗
• MalfunctionAug 11, 2023Structural Problem; Structural Problem

  AS REPORTED, THE PROXIMAL MARKER BAND ON THE BALLOON OF A 4MM X 4CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS DISPLACED; HOWEVER, THE MARKER BAND REMAINED ON THE BALLOON CATHETER. DESPITE THE MALFUNCTION, THE SABER PTA BALLOON CATHETER WAS USED TO DILATE A SUPERFICIAL FEMORAL ARTERY (SFA) LESION AND WAS SUCCESSFULLY INFLATED TO 10 ATMOSPHERES (ATM). THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS BEING USED INSIDE OF THE PATIENT. THERE WERE NO DIFFICULTIES INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS ABLE TO BE DEFLATED AND REMOVED FROM THE PATIENT WITHOUT ISSUE, AND THE DEVICE REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508428 ↗
• MalfunctionOct 4, 2021Partial Blockage; Partial Blockage

  DURING THE DEVICE PREPARATION PROCEDURE, THE 4MM X 4CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE FLUSHED BECAUSE THE UNKNOWN GUIDEWIRE LUMEN PORT ON THE BALLOON WAS CLOGGED/BLOCKED CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. SO, IT COULD NOT BE USED ON PATIENT AND ANOTHER SABER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEM.. THERE WAS NO REPORTED PATIENT INJURY. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS BEING PERFORMED. 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. THE EVENT OCCURRED DURING THE INITIAL USE OF THE DEVICE. PATIENT DEMOGRAPHICS AND MEDICAL HISTORY WERE REQUESTED BUT WERE NOT AVAILABLE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568371 ↗
• MalfunctionOct 15, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 4MM X 4CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT EXPAND, AND THE AIR LEAKED OUT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683218 ↗
• MalfunctionAug 15, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE SABER BALLOON CATHETER (BC) BURST AT SIX ATMOSPHERE (6 ATM) WITHIN ITS NOMINAL PRESSURE DURING ITS INITIAL INFLATION. THERE WAS NO PATIENT INJURY. THE SABER BC WAS REPLACED WITH ANOTHER HIGH PRESSURE BALLOON, THEN THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY AND WAS HEAVILY CALCIFIED. THE RUPTURE WAS CONFIRMED BY CONTRAST MEDIA LEAKAGE. THE PATIENT DID NOT HAVE INFECTIOUS DISEASES. THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896296 ↗

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