SABER 48007004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032068847), received between Nov 22, 2017 and Mar 31, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7MM 4CM SABER PTA WAS USED AT THE CALCIFIED LESION. HOWEVER, IT RUPTURED BEFORE THE BALLOON INFLATED COMPLETELY. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER (NON-CORDIS) AND IT COULD BE INFLATED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS IN THE ILIAC ARTERY WHICH HAD AN OCCLUSION. AN IPSILATERAL ANTEGRADE APPROACH WAS MADE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009312 ↗
• MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER PTA WAS USED BUT IT RUPTURED AT 6 ATM DURING ITS INITIAL INFLATION. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER SABER (8MM*4CM) AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A VAIVT CASE. THE LESION WAS A STENOSIS AT THE BRACHIAL VEINS. A UNKNOWN GUIDEWIRE (0.018) CROSSED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238854 ↗
• MalfunctionOct 26, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING POST-DILATATION OF A LESION IN THE ILIAC ARTERY WITH 90% STENOSIS, A 7X4CM SABER RX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 8 ATMOSPHERES DURING ITS INITIAL INFLATION. IT WAS REPLACED WITH ANOTHER SABER RX OF THE SAME SIZE WHICH WAS INFLATED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS A LITTLE CALCIFIED WITH A LITTLE CALCIFICATION. THE PROCEDURE BEING PERFORMED WAS AN ENDOVASCULAR ILIAC TREATMENT CASE. THE ACCESS SITE WAS THE LEFT FEMORAL. INITIALLY, THE LESION WAS PRE-DILATED WITH A 6X4CM SABER PTA BALLOON CATHETER AND A SMART STENT WAS IMPLANTED. THERE WAS NO DIFFICULTY REMOVING THE COMPLAINT BALLOON FROM THE FORMING TUBE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50:50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699125 ↗
• MalfunctionJul 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING VASCULAR ANGIOGRAPHY, A 7MM X 4CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULDN¿T THREAD ONTO THE UNKNOWN WIRE AND IT WAS NOTED THAT THE END OF THE BALLOON HAD SHEARED OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223517 ↗
• MalfunctionMay 21, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING AN ENDOVASCULAR THERAPY CASE (EVT), A 7MM X 4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AS A PRE-DILATION AFTER AN UNKNOWN GUIDEWIRE CROSSED THE LESION, HOWEVER IT RUPTURED AT 6ATM (ATMOSPHERES). IT WAS THEN REPLACED WITH ANOTHER SAME SIZED BALLOON CATHETER AND A DRUG COATED BALLOON CATHETER WAS USED AS WELL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS ISSUE MIGHT HAVE BEEN CAUSED DUE TO CALCIFICATION. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10079396 ↗
• MalfunctionMar 3, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM X 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS INFLATED HOWEVER, IT RUPTURED AT APPROXIMATELY 6 ATMOSPHERES (ATM) IN ITS INITIAL INFLATION. THEREFORE, IT WAS REMOVED FROM THE PATIENT¿S BODY AND THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A NEW NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS POSTERO-ANTERIOR (PA) INFLATION CASE IN PEDIATRICS. A SV WIRE WAS CROSSED THE LESION. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY BY MAINTAIN NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING 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 INDEFLATOR/SYRINGE USED WAS AN EVEREST MEDTRONIC. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESIST

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9783123 ↗
• MalfunctionJul 11, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER PTA BALLOON CATHETER (7MM4CM 90) WAS USED FOR INFLATION AT ITS NOMINAL PRESSURE FOR TWO MINUTES. HOWEVER, THE SABER PTA BALLOON RUPTURED AT APPROXIMATE 11-TO-12 ATMOSPHERES PRESSURE (ATM). THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, THE SABER PTA BALLOON WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND IT WAS INFLATED. THE PROCEDURE WAS COMPLETED. THE LESION WAS THE LEFT SUBCLAVIAN ARTERY WHICH HAS STENOSIS. INITIALLY, A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780295 ↗
• MalfunctionNov 22, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE SABER BALLOON CATHETER (BC) RUPTURED AT SIX (6) ATMOSPHERE (ATM). IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. A CONTRALATERAL APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY WITH A NON CORDIS GUIDING SHEATH. A NON CORDIS GUIDEWIRE CROSSED THE LESION AND A SABER BC WAS DELIVERED TO THE LESION FOR INFLATION, HOWEVER, IT RUPTURED. THE TARGET LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052408 ↗

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