SABER 48002015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20705032069202), received between Jul 18, 2019 and Sep 12, 2025 — classified as 13 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING INFLATION OF A 2MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO 15 ATMOSPHERES (ATM), NO BALLOON EXPANSION WAS OBSERVED. SUBSEQUENT ASPIRATION OF THE BALLOON REVEALED BLOOD WITHIN THE INDEFLATOR, CONSISTENT WITH A BALLOON RUPTURE. A NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A RIGHT ANTERIOR TIBIAL ARTERY LESION. THE TARGET VESSEL EXHIBITED MODERATE CALCIFICATION AND 80% STENOSIS. AN UNKNOWN .018 GUIDEWIRE WAS SUCCESSFULLY ADVANCED THROUGH THE LESION INTO THE DISTAL TRUE LUMEN, AND THE SABER PTA BALLOON CATHETER WAS POSITIONED ACROSS THE LESION PRIOR TO ATTEMPTED INFLATION. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DIFFICULTIES WERE ENCOUNTERED DURING THE REMOVAL OF THE STERILE PACKAGING. NEGATIVE PRESSURE WAS MAINTAINED DURING PREPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039240 ↗
• MalfunctionSep 10, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AS REPORTED, A 2MM 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS THEN POSITIONED ACROSS THE LESION. DURING INFLATION USING A PRESSURE PUMP/INDEFLATOR, NO BALLOON EXPANSION WAS OBSERVED. SUBSEQUENT ASPIRATION REVEALED BLOOD WITHIN THE INDEFLATOR, CONSISTENT WITH BALLOON RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NON-CORDIS .018 BALLOON OF THE SAME SIZE. THERE WAS NO REPORTED INJURY TO THE PATIENT. AN UNKNOWN 0.018-INCH GUIDEWIRE WAS SUCCESSFULLY ADVANCED THROUGH THE POSTERIOR TIBIAL ARTERY LESION INTO THE DISTAL TRUE LUMEN. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES NOTED DURING REMOVAL FROM THE HOOP, PROTECTIVE COVER, OR STERILE PACKAGING, AND NO DAMAGE WAS OBSERVED BEFORE USE. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE PROCEDURE TARGETED A 100% STENOSED, MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY WITH NO VESSEL TORTUOSITY. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO ISSUES WITH RESISTANCE DURING INSERTION OR ADVANCEMENT, AND THE CATHETER DID NOT EXPERIENCE ACUTE BENDS OR KINKING. THE CONTRAST-TO-SALINE RATIO WAS 50%. THE DEVICE WILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018461 ↗
• MalfunctionMar 25, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 2MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION BELOW ITS BURST PRESSURE. A NEW 2MM X 15CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A LOWER EXTREMITY INFRAPOPLITEAL ARTERY. THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED SEVERE CALCIFICATION, MODERATE TORTUOSITY, AND 80% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS 1:1. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691081 ↗
• MalfunctionDec 6, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  AS REPORTED, THE BALLOON FOR A 2MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE DEFLATED. THE BALLOON WAS NOT DEFLATED PRIOR TO REMOVAL AND WAS FINALLY REMOVED BY VIOLENT YANKING. A NON-CORDIS BALLOON WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS BELOW-THE-KNEE. THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED NO CALCIFICATION, NO TORTUOSITY, AND 30% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865559 ↗
• MalfunctionAug 14, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE BALLOON OF A 2MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE INFLATED DURING ITS USE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A PIECE OF FOREIGN MATERIAL OBSTRUCTING THE INFLATION LUMEN OF THE SABER PTA BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546640 ↗
• MalfunctionMar 6, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 2MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED NORMALLY BUT HAD RUPTURED PRIOR TO REACHING THE PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486586 ↗
• MalfunctionDec 2, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  AS REPORTED, WHEN THE VASCULAR SURGERY DEPARTMENT HANDLED THE OCCLUSION OF THE LOWER LIMB ARTERY WITH AN OCCLUSION, THE BALLOON OF THE 2MM15CM SABER COULD NOT BE INFLATED UNDER PRESSURE WITH PRESSURE PUMP. THE BALLOON HAD A PINHOLE. THIS WAS CONFIRMED AFTER WITHDRAWING THE BALLOON AND INFLATING THE BALLOON WITH SALINE, IT WAS FOUND THERE WAS PINHOLE ON THE BALLOON. THE PRODUCT EVAL CONFIRMED THE BODY/SHAFT HAD A RUPTURE. THE OPERATOR WITHDREW IT FROM THE PATIENT'S BODY INTACT AND REPLACED WITH ANOTHER BRAND (NON-CORDIS) BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE OPERATOR WAS A CORDIS PROFESSIONAL TRAINER. THE PRODUCT 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 PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY AND WAD ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN A LOWER EXTREMITY ARTERIAL WITH AN OCCLUSION. THE LESION WAS NOTED TO HAVE A LITTLE CALCIFICATION WITH NO VESSEL TORTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906234 ↗
• MalfunctionApr 28, 2022Partial Blockage; Material Integrity Problem; Partial Blockage; Material Integrity Problem

  AS REPORTED, A NON-CORDIS .018 GUIDEWIRE WAS UNABLE TO PASS THROUGH A 2MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WHILE BEING PRE-LOADED OUTSIDE OF THE PATIENT. ADDITIONALLY, IT WAS REPORTED THERE WAS DIFFICULTY EXPERIENCED WHEN ATTEMPTING TO FLUSH THE SABER PTA BALLOON CATHETER DURING PREPARATION. AS A RESULT, A 2MM X 20CM 150CM SABER PTA BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE 2MM X 15CM 150CM SABER PTA BALLOON CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO OBSERVED KINKS TO THE DEVICE. THE NON-CORDIS GUIDEWIRE THAT WAS USED WAS NOT DAMAGE IN ANY WAY AND WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THIS PROCEDURE. THE TARGET LESION WAS CALCIFIED AND HAD A STENOSIS OF 80%; HOWEVER, THERE WAS NO EVIDENCE OF AN ACUTE ANGLE OR BIFURCATION PRESENT AT THE TARGET SITE. INFORMATION REGARDING THE TARGET SITE, VESSEL TORTUOSITY, AND THE POSSIBILITY OF AN INJECTABLE OBSTRUCTION WAS REQUESTED BUT NOT PROVIDED, AND THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION ON (B)(6) 2022 REVEALED A PIECE OF DETACHED INNER BODY POLYET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14238306 ↗
• MalfunctionJun 14, 2021Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 2MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) COULD NOT PASS OVER THE NON-CORDIS GUIDEWIRE, SO THE BALLOON WAS NOT SUCCESSFULLY ADVANCED INTO THE PATIENT'S BLOOD VESSEL AND DIRECTLY EXITED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION. A SECONDARY FAILURE WAS OBSERVED DURING THE EVALUATION OF THE UNIT. THE GUIDEWIRE LUMEN WAS OBSERVED TORN/RUPTURED. IT WAS REPORTED THAT THE DEVICE WAS OPENED IN STERILE FIELD. THE SURGEON PERFORMED BALLOON DILATATION FOR PATIENTS WITH LOWER EXTREMITY ARTERY OCCLUSION. FIRST, THE NON-CORDIS GUIDEWIRE WAS USED TO OPEN THE BLOOD VESSEL, AND THEN THE SABER BALLOON CATHETER WAS USED TO DILATE THE DISEASED BLOOD VESSEL. THE TARGET SITE WAS A BALLOON ANGIOPLASTY OF RIGHT ANTERIOR TIBIAL ARTERY. THE ACCESS SITE WAS FEMORAL. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE LESION WAS SEVERELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THERE WAS OCCLUSIVE LESION. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE DID NOT KINK NOR BEND AT ANY TIME PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11989852 ↗
• MalfunctionApr 12, 2021Leak/Splash; Leak/Splash

  DURING AN INTERVENTIONAL PROCEDURE ON AN ATHEROSCLEROTIC OCCLUSION OF THE LOWER EXTREMITY IN THE ANTERIOR TIBIAL ARTERY, A 2MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS BROKEN AS THE BALLOON FAILED TO FILL NORMALLY, AND LEAKAGE WAS NOTED FROM THE BALLOON WHEN ENTERING THE PATIENT'S BODY FOR BALLOON DILATATION. THE OPERATION WAS SUCCESSFULLY COMPLETED BY CHANGING TO ANOTHER SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE 90% OCCLUDED LESION WAS CALCIFIED BUT THERE WAS NO VESSEL TORTUOSITY. 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 RATION WAS 1:1. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PLUNGER DEPRESSED INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. ADDITIONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11652203 ↗
• MalfunctionMar 8, 2021Partial Blockage; Partial Blockage

  AS REPORTED, THE NON-CORDIS WIRE COULD NOT PASS THROUGH THE CAVITY OF THE 2MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. AFTER FLUSHING, THERE WAS NO HEPARINIZED SALINE OUTFLOW AT THE HEAD-END OF THE GUIDEWIRE. THE SAME WIRE WAS USED WITH ANOTHER CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. ANALYSIS OF THE RETURNED DEVICE INDICATED A RIPPED/ TORN LITTLE PIECE OF NYLON FROM THE INNER GUIDE WIRE LUMEN WAS FOUND TUCKED AT THE AFFECTED OBSTRUCTED AREA. THE NON-CORDIS WIRE WAS FLUSHED AND/OR WIPED DOWN PRIOR TO ATTEMPTING TO THE LOAD THE DEVICE ONTO THE WIRE. THE WIRE WAS IN-VITRO FOR 3 MINUTES BEFORE ATTEMPTING TO LOAD THE BALLOON ONTO THE WIRE. THE INSERTION DIFFICULTY WAS NOT CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THE SABER WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. IT WAS ALSO PREPPED PROPERLY ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY REPORTED FLUSHING THE CATHETER PRIOR TO USE AND NO PROBLEMS DURING PREPPING. THE DEVICE WILL BE RETURNED FOR ANALYSIS. IMAGES ARE AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439171 ↗
• MalfunctionDec 18, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 2 MM X 15 CM 150 SABER WAS RUPTURE THROUGH THE LESION AT 10 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER BALLOON. THE CONTRAST AGENT LEAKED, AND THE BALLOON WAS WITHDRAWN. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS ANTERIOR TIBIAL ARTERY (ATA). THE VESSEL LEVEL OF CALCIFICATION IS MODERATE. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED IN THE CATH LAB ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS STORED IN THE CATH LAB FOR THREE MONTHS. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY. 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. A MON-CORDIS CONTRAST MEDIA USED. THE CONTRAST TO SALINE RATIO WAS 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS NOR DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON RUPTURED AT TEN ATMOSPHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9488674 ↗
• MalfunctionJul 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE SHAFT OF THE SABER 2MM15CM 150 WAS BROKEN DURING THE PROCEDURE. THERE WERE NO REPORTED PATIENT INJURIES. ADDITIONAL INFORMATION OBSERVED FROM THE PRODUCT ANALYSIS STATES THAT THE BODY/SHAFT OF THE DEVICE WAS SEPARATED, AND THE EDGES OF THE SEPARATION LOOKS ELONGATED. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BODY/SHAFT WAS SEPARATED. THERE WAS NO KINKS/BENDS IN THE DEVICE. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE SABER WAS REMOVED AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802018 ↗

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