SABER 48003025XRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032069127), received between Apr 30, 2019 and Aug 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Leak/Splash; Leak/Splash

  AS REPORTED, DURING THE DILATION OF A 3MM X 25CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, BALLOON LEAKAGE OCCURRED WITH CONTRAST MEDIA "EXTRAVASATION". THE TERM ¿EXTRAVASATION¿ WAS USED TO DESCRIBE CONTRAST LEAKAGE INTO THE VESSEL LUMEN DISTALLY DURING BALLOON INFLATION. NO EXTRAVASATION INTO SURROUNDING TISSUE WAS OBSERVED AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. AN UNKNOWN 3MM X 25MM BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THIS WAS DURING A PROCEDURE TO TREAT A LOWER LIMB LEFT PERONEAL ARTERY BELOW THE KNEE. THE TARGET VESSEL WAS MODERATELY CALCIFIED, NOT TORTUOUS, AND EXHIBITED 70% STENOSIS. THE DEVICE WAS STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH NO DIFFICULTY ENCOUNTERED IN REMOVING STERILE PACKAGING. NEGATIVE PRESSURE WAS MAINTAINED DURING PREPARATION. A 50:50 RATIO OF CONTRAST TO SALINE WAS USED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921245 ↗
• MalfunctionOct 7, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM 25CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS LEAKING OUT OF BOX. THE BALLOON WAS NOT ABLE TO INFLATE. THE PRODUCT EVALUATION CONFIRMED THE BALLOON HAD A RUPTURE ON THE BALLOON SURFACE. THE PROCEDURE WAS COMPLETED WITH A NEW .018 SABER. THE BALLOON WAS NOT USED AT ALL IN THE PATIENT. 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 PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OTHER STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED TO THE DEVICE. THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NOT KINKED. THE CONTRAST/ SALINE RATIO WAS 50/50. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385486 ↗
• MalfunctionSep 23, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM 25CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED BELOW RATED BURST PRESSURE (RBP), AND EXTRAVASATION OF CONTRAST MEDIUM OCCURRED. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY SWITCHING TO ANOTHER BALLOON, SPECIFICALLY A BALLOON, SHEATH, AND A PRESSURE PLUNGE DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS AN ARTERIAL OCCLUSION OF THE LOWER LIMBS. THE PRODUCT WAS STORED CORRECTLY AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING IT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE OBSERVED PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE WAS PREPARED ACCORDING TO THE IFU AND WAS PREPPED NORMALLY. THE PROCEDURE WAS INTENDED TO TREAT A STENOTIC LESION, WHICH WAS CALCIFIED. THE VESSEL TORTUOSITY WAS MILD, AND THE STENOSIS WAS AT 90%. THERE WAS NO RESISTANCE OR FRICTION NOTED WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR WHILE CROSSING THE LESION. THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279213 ↗
• MalfunctionJul 24, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 3MM 25CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT 8ATM DURING WAS USE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE INTENDED PROCEDURE WAS A ILIAC AND BILATERAL LOWER LIMB BALLOONING. 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 TO THE DEVICE PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE MILD CALCIFICATION. THE VESSEL HAD MILD TORTUOSITY. THE LESION HAD A 70% STENOSIS. 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 RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON CATHETER THROUGH THE UNKNOWN GUIDE CATHETER. THERE WAS NO DIFFICULTY NOTED WHILE ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY NOTED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819060 ↗
• MalfunctionSep 15, 2023Leak/Splash; Leak/Splash

  AS REPORTED A BALLOON LEAK WAS REPORTED FOR THE 0.18 SABER 3MM X 25CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER. THE ANOMALY WAS NOTED WHILE INFLATING THE DEVICE WITH POSITIVE PRESSURE; LEAKING WAS FOUND DURING FILLING. NO BALLOON TEAR OR PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED BY CHANGING TO A NEW UNKNOWN BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE ARTERIOSCLEROSIS OCCLUSION OF THE LOWER LIMBS. VESSEL CALCIFICATION WAS MILD; THERE WAS NO VESSEL TORTUOSITY WITH SEVENTY PERCENT (70%) STENOSIS. THE DEVICE WAS NOT USED OR A CTO GREATER THAN THREE (3 MONTHS. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER NOR DIFFICULTY REMOVING THE 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 MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. CONTRAST MEDIA WAS USED AND THE CONTRAST TO SALINE RATIO WAS 1:1. A PRESSURE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754915 ↗
• MalfunctionMay 26, 2023Leak/Splash; Leak/Splash

  AS REPORTED, THE SABER 3MM 25CM BALLOON WAS USED FOR INTERVENTIONAL TREATMENT OF AN ARTERIOSCLEROSIS OCCLUSION OF THE LOWER EXTREMITIES. HOWEVER, IT WAS FOUND THAT THE BALLOON LEAKED, AND THE PRESSURE PUMP COULD NOT INFLATE THE BALLOON. A NEW BALLOON WAS REPLACED TO COMPLETE THE OPERATION WITHOUT ANY INJURY TO THE PATIENT. THE SURGEON HAS EXTENSIVE EXPERIENCE WITH SABER BALLOONS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011038 ↗
• MalfunctionApr 30, 2019Partial Blockage; Partial Blockage

  AS REPORTED, A SABER 3MM X 25CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) COULD NOT BE FLUSHED WITH HEPARINIZED SALINE. THE GUIDEWIRE COULD NOT PASS THROUGH THE BALLOON AND THE GUIDEWIRE WAS USED TO PASS THROUGH A WHITE FOREIGN BODY ABOUT 1CM LONG. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS CALCIFIED. THERE WAS NOT ANY VESSEL ANGULATION. THE DEVICE WAS NOT BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE TARGET LESION WAS THE ANTERIOR TIBIAL ARTERY. A CONTRALATERAL APPROACH WAS NOT USED. THE DEVICE DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE OR FRICTION. THE SAME GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK OR BEND AT ANY TIME. THE BLOCKAGE CAUSED BY THE MATERIAL COULD NOT BE INSERTED INTO THE PATIENT AND CAUSE HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8565091 ↗

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