SABER 48005006XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032068137), received between Feb 15, 2019 and Jun 4, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4.0MM X 40MM SABER .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND A 5MM X 6CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED ON FIRST INFLATION. THE DEVICES WERE REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NEW NON-CORDIS BALLOONS. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WERE STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING EITHER DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR DAMAGES NOTED PRIOR TO INSERTING EITHER PRODUCT INTO THE PATIENT. THE DEVICES WERE PREPPED PER THE IFU AND WERE DONE SO NORMALLY. THEY WERE ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREP. THE INTENDED LESION WAS IN THE ANTERIOR TIBIAL VESSEL FOR REVASCULARIZATION. THE VESSEL WAS NOTED TO HAVE LITTLE TORTUOSITY. THE LESION HAD SEVERE CALCIFICATION. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING EITHER OF THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOONS THROUGH THE VESSEL. THE CATHETERS WERE NEVER IN AN ACUTE BEND. THE CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463329 ↗
• MalfunctionSep 14, 2023Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 5MM X 6CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WOULD NOT INFLATE WITHIN THE ARTERY AND APPEARED TO HAVE A HOLE IN IT. PRESSURE WAS NOT MAINTAINED AND CONTRAST LEAKED OUT FROM A HOLE IN THE BALLOON. THE GAUGE OF THE INDEFLATOR INDICATED A LOSS OF PRESSURE WHEN THE ANOMALY WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NEW UNKNOWN BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE AN ANGIOGRAM WITH RUNOFF. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL CALCIFICATION AND TORTUOSITY WAS MILD. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). 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. THE CONTRAST TO SALINE RATIO WAS 50:50

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743603 ↗
• MalfunctionJul 13, 2023Deflation Problem; Deflation Problem

  AS REPORTED, THE SABER 5MM 6CM BALLOON WAS DIFFICULT TO DEFLATED TO ITS ORIGINAL STATE AFTER INFLATION. THEN THE BALLOON WAS INFLATED AGAIN, IT WAS FOUND COULD NOT BE FULLY INFLATED. THEN THE BALLOON WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE RIGHT ANTERIOR TIBIAL ARTERY WAS OCCLUDED ON IMAGING WITH A PARALLEL PUNCTURE TO THE RIGHT FEMORAL ARTERY. THE PRODUCT 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 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 NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS IN THE LOWER EXTREMITY AND THE GOAL WAS TO OBTAIN A LARGER LUMEN. THE LESION DID NOT HAVE ANY CALCIFICATION. THE LESION HAD A 75% 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 BALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316665 ↗
• MalfunctionJul 2, 2021Leak/Splash; Leak/Splash

  AS REPORTED, THERE WAS LEAKAGE AT THE POINT BETWEEN THE BALLOON OF THE 5MM X 6CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND THE NON-CORDIS PRESSURE PUMP. THERE WAS LIQUID EXUDATION WHEN NORMAL SALINE WAS INJECTED INTO THE PLACE WHERE THE BALLOON Y-VALVE INTERFACE WAS CONNECTED WITH THE PRESSURE PUMP. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS WAS NOTED. THE DEVICE HAS NO KINKS OR OTHER DAMAGES PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE FEMORAL SUPERFICIAL ARTERY (SFA) WAS THE INTENDED TARGET. THE SFA HAD A STENOSIS TO BE TREATED. THE LESION HAD BOTH MILD CALCIFICATION AND VESSEL TORTUOSITY. THE LESION HAD A 30% STENOSIS; HOWEVER, THE DEVICE WAS USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). A NON-CORDIS INDEFLATOR WAS USED DURING THE CASE AND WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12106676 ↗
• 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 8344646 ↗

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