SABER 48005015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20705032069189), received between Mar 9, 2019 and Mar 6, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM 15CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING DILATATION OF THE LOWER EXTREMITY ARTERY. THE BALLOON WAS WITHDRAWN FOR EXAMINATION AND REPLACED WITH A NEW SABER BALLOON TO CONTINUE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THE OPERATOR WAS CERTIFIED TO USE THE SABER BALLOON. THERE WERE NO OBVIOUS SIGNS OF DAMAGE TO THE DEVICE OR PACKAGING PRIOR TO USE. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536683 ↗
• MalfunctionOct 30, 2023Partial Blockage; Partial Blockage

  AS REPORTED, A NON-CORDIS .018 GUIDEWIRE WAS UNABLE TO BE ADVANCED INTO A 5MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER FROM THE DISTAL END. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE GUIDEWIRE BUT WERE UNSUCCESSFUL AND THE SABER PTA BALLOON CATHETER WAS ABANDONED. THE PROCEDURE WAS COMPLETED USING THE SAME .018 NON-CORIS GUIDEWIRE AND A NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS TORTUOUS AND MORE THAN 70% STENOSED. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED AN OBSTRUCTION CAUSED BY A PORTION OF THE GUIDEWIRE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031518 ↗
• MalfunctionNov 18, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 5MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST WHILE INSIDE OF THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A CALCIFIED LESION WHICH WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS, AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO TRACK TOWARD THE LESION AND CROSS THE LESION WITHOUT DIFFICULTY. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND AND DID NOT KINK DURING ITS USE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824804 ↗
• MalfunctionOct 26, 2022Partial Blockage; Partial Blockage

  AS REPORTED, THE BALLOON OF A 5MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO BE INFLATED WHILE ATTEMPTING TO TREAT A RIGHT SUB-KNEE OCCLUSION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO DILATE THE TIBIOFIBULAR TRUNK IN WHICH THE 5MM X 15CM 150CM SABER PTA BALLOON CATHETER WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, ANY OF THE STERILE PACKAGING COMPONENTS, AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. NO LEAKAGE WAS EVER OBSERVED FROM ANYWHERE ON THE DEVICE. THE BALLOON CATHETER WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING REMOVAL. INFORMATION REGARDING THE TARGET VESSEL CHARACTERISTICS, CONTRAST USED, CONTRAST TO SALINE RATIO, INFLATION DEVICE USED, AND THE COMPLETION OF THE PROCEDURE WAS REQUESTED BUT WAS NOT PROVIDED, AND THE DEVICE WAS NOT RETURNED AS EXPECTED. ADDENDUM: PRODUCT EVALUATION ON 19-OCT-2022 REVEALED A PIECE OF DETACHED INNER BODY POLYETHYLENE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676711 ↗
• MalfunctionDec 23, 2021Partial Blockage; Partial Blockage

  AS REPORTED, THE SCRUB NURSE TRIED TO FLUSH A SABER 5MM15CM 150 BUT IT WOULD NOT FLUSH. THE DEVICE WAS REPLACED WITH ANOTHER SABER BALLOON CATHETER AND IT WAS FLUSHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE ISSUE OCCURRED DURING PREP FOR A PTA PROCEDURE. THE DEVICE WAS INSPECTED FOR DAMAGES PRIOR TO USE AND THERE WERE NO VISIBLE DAMAGES; ONLY THE REPORTED ISSUE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THE PHYSICIAN ALSO ATTEMPTED TO FLUSH THE DEVICE BUT WAS UNABLE TO. IT SEEMED "AS IF THE TIP WAS CLOSED". NO SOLUTION WOULD THE CATHETER WHEN ATTEMPTING TO FLUSH. THE DEVICE WAS LATER RETURNED FOR ANALYSIS. ADDENDUM: PRODUCT ANALYSIS REVEALED A PIECE OF AN UNKNOWN MATERIAL TUCKED INSIDE THE GUIDE WIRE LUMEN COULD BE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13074925 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A CORDIS 5MM BALLOON WAS USED TO EXPAND A 6MM X 150MM X 120CM SMARTFLEX VASCULAR (VAS) SELF-EXPANDING STENT; HOWEVER, AFTER THE EXPANSION OF THE BALLOON IT WAS NOTICED THAT THERE WAS A STENOSIS AT THE DISTAL END OF THE STENT, AND THE STENT WAS DIFFICULT TO OPEN. THE 5MM BALLOON WAS THEN REPLACED WITH A 6MM X 8CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER; HOWEVER, THERE WAS STILL STENOSIS NOTED AFTER POSTERIOR EXPANSION. THE PHYSICIAN FIRST USED A 3MM X 15CM 150 SABER PTA BALLOON CATHETER TO EXPAND THE OCCLUSIVE SEGMENT, THEN WITHDREW THE BALLOON, AND SWITCHED TO A 5MM X 15CM 150 SABER PTA BALLOON CATHETER FOR EXPANSION. AFTER THE EXPANSION WAS COMPLETED, THE INTRATHECAL ANGIOGRAPHY SHOWED THAT THERE WAS A DISSECTION IN THE SUPERFICIAL FEMORAL ARTERY. THE INTRATHECAL ANGIOGRAPHY SHOWED THE BLOOD FLOW IN THE SUPERFICIAL FEMORAL ARTERY OF THE RIGHT LOWER LIMB WAS FAIR. IT WAS DECIDED TO PLACE TWO VASCULAR STENTS. THE CATHETER WAS WITHDRAWN, AN EXOSEAL WAS USED TO COMPLETE HEMOSTASIS. MANUAL PRESSURE WAS HELD FOR 5 MINUTES AND THEN A BANDAGE WAS ADDED. ANTICOAGULATION THERAPY WAS PLANNED FOR POSTOPERATIVE CARE AND THE PROCEDURE WAS COMP

  Patient problems: Vascular Dissection

  MAUDE report 12897036 ↗
• MalfunctionApr 12, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, A 5MM X 15CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED TO DILATE FEMORAL POPLITEAL TIBIAL AND FIBULAR ARTERY STENT; HOWEVER, THE BALLOON CANNOT BE FULLY FILLED. THE BALLOON CATHETER WAS NOT REMOVED EASILY. AN UNKNOWN SABER 5 X 200 WAS USED TO DILATE AND FILL IT COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD LOWER EXTREMITY ARTERIOSCLEROSIS OBLITERANS. LOCAL ANESTHESIA WAS USED, AND AN UNKNOWN PUNCTURE SHEATH WAS USED. AFTER THE ANGIOGRAPHY SHOWED THAT THE BEGINNING OF THE RIGHT SUPERFICIAL ARTERY WAS UNOBSTRUCTED. THE RIGHT SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY AND TIBIOFIBULAR ARTERY HAD STENT OCCLUSION. THE LESION WAS MODERATELY CALCIFIED. THERE WAS LITTLE TO NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 60%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR 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 DEVICE WAS PREPPED NORMALLY (I.E., MAINTAIN NEGATIVE PRESSURE). THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647267 ↗
• MalfunctionJan 12, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THREE , 2MM X 4CM 150, 5MM X 15CM 150, AND 2.5MM X 4CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETERS BURST DURING INFLATION PRIOR TO NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICESTHE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154363 ↗
• MalfunctionOct 19, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF THE 5MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER HAS UNKNOWN CONTRAST AGENT LEAKAGE IN THE MIDDLE OF THE CAPSULE. IT CANNOT BE FULLY FILLED. IT WAS SUSPECTED THAT THE BALLOON WAS RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DISTAL END OF THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS OCCLUDED ABOUT 15CM IN LENGTH. THE OPERATION TOOK THE LEFT FEMORAL ARTERY PUNCTURE AND ¿TURNED OVER THE MOUNTAIN¿, USING A NON-CORDIS V18 GUIDEWIRE TO OPEN THE LESION, THEN BALLOON DILATATION AND UNKNOWN STENT IMPLANTATION. THEY MENTIONED POOR USE OF SABER AFTER DILATATION. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10696482 ↗
• MalfunctionApr 24, 2020Burst Container or Vessel; Burst Container or Vessel

  THE 5MM X15CM X 150MM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD CROSS THE LESION HOWEVER IT RUPTURED AT ITS NOMINAL PRESSURE AND IT WAS REMOVED FROM THE PATIENT¿S BODY. THEREFORE, THE SABER BALLOON CATHETER WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE SABER BALLOON CATHETER WAS ATTEMPTED TO BE USED FOR PRE- PLAIN OLD BALLOON ANGIOPLASTY (POBA). THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS PREPPED WITHOUT ANY ISSUES AND WILL NOT BE RETURNED FOR ANALYSIS SINCE IT WAS DISCARDED WAS BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9995675 ↗
• MalfunctionJul 10, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER 5MM15CM 150 WAS DELIVERED TO THE LESION AND INFLATED, HOWEVER, IT RUPTURED AT EIGHT ATMOSPHERES DURING ITS INITIAL INFLATION. THERE WERE NO REPORTED PATIENT INJURIES. THE SABER WAS REPLACED WITH A NEW BALLOON CATHETER (5MM*10CM) AND IT WAS INFLATED WITHOUT ANY ISSUE. A SMART WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO). ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8778511 ↗
• MalfunctionMar 9, 2019Structural Problem; Structural Problem

  AS REPORTED, THE MARKER BANDS ON A SABER BALLOON CATHETER (5MM15CM 150) WERE OUT OF POSITION. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406355 ↗

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