SABER 48003015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20705032069103), received between Dec 26, 2018 and Jan 30, 2026 — classified as 1 injury, 13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Leak/Splash

  AS REPORTED, THE BALLOON OF A 3MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND TO HAVE AN AIR LEAK DURING NEGATIVE PREPARATION. THE DEVICE WAS NOT USED INSIDE THE PATIENT, AND A NON-CORDIS BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EVENTS OR INJURIES TO THE PATIENT. THE INTENDED PROCEDURE WAS PERIPHERAL ARTERY ANGIOPLASTY OF THE LOWER LIMB. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER, AND THE COVER DID NOT TWIST OR ROTATE DURING REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223277 ↗
• InjuryNov 25, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, A 3MM X 15CM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS THEN USED IN PATIENT. THE BALLOON WAS INFLATED UP TO RBP, AND THERE WAS A LOSS OF PRESSURE DURING INFLATION DUE TO RUPTURE. ADDITIONALLY, DEFLATION TOOK LONGER THAN USUAL. AFTER BALLOON INFLATION AND DEFLATION OF A 3MM X 15CM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE DEVICE WAS REMOVED. HOWEVER, ANGIOGRAPHY REVEALED THAT THE MARKER BAND OF THE SABER .018 PTA BALLOON CATHETER WAS STILL VISIBLE. UPON INSPECTION, IT WAS FOUND THAT THE SHAFT HAD FRACTURED, LEAVING A PORTION INSIDE OF THE PATIENT¿S VESSEL. APPROXIMATELY HALF OF THE SHAFT WAS RETRIEVED USING AN UNKNOWN SNARE, WHILE THE REMAINING PORTION COULD NOT BE REMOVED AND REQUIRED SURGICAL EXTRACTION BY OPENING THE VESSEL. RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE PRIOR TO OBSERVING THE SEPARATION, SPECIFICALLY FROM THE VESSEL AND THROUGH THE SHEATH/INTRODUCER GUIDE. THREE IMAGES WERE PROVIDED WHICH SHOW THE SEPARATION OCCURRED AT THE BALLOON PORTION OF THE DEVICE. THE PATIENT DID NOT SUFFER ANY SERIOUS INJURIES AND WAS SENT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645920 ↗
• MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHILE ADVANCING A 3MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER OVER AN UNKNOWN GUIDEWIRE, THE TIP OF THE DEVICE SEPARATED FROM THE BALLOON. THE SEPARATION OCCURRED PRIOR TO BEING IN CONTACT WITH THE UNKNOWN SHEATH. THE DEVICE DID NOT ENTER THE PATIENT, AND THE SAME GUIDEWIRE WAS USED WITH AN UNKNOWN REPLACEMENT DEVICE. THERE WERE NO REPORTED PATIENT INJURIES. THIS WAS DURING THE FIRST USE OF THE SABER PTA BALLOON CATHETER. THE DEVICE WAS PREPPED AND INSPECTED PRIOR TO INSERTING OVER THE UNKNOWN GUIDEWIRE AND THERE WERE NO ABNORMALITIES NOTED. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR APPLYING NEGATIVE PRESSURE TO THE SABER PTA BALLOON. THERE WAS NO DAMAGE TO THE UNKNOWN GUIDEWIRE. THERE WAS NO RESISTANCE OR FRICTION BETWEEN THE SABER PTA AND THE GUIDEWIRE PRIOR TO THE SEPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912091 ↗
• MalfunctionMar 21, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 3MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WHEN BEING FILLED UNDER RATED BURST PRESSURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A LOWER EXTREMITY ARTERIOGRAPHY WITH BALLOON DILATATION AND STENT IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663701 ↗
• MalfunctionDec 7, 2024Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AS REPORTED, THE BALLOON OF A 3MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED, AND CONTRAST LEAKAGE WAS OBSERVED WHEN THE BALLOON WAS COMPLETELY INFLATED INSIDE OF THE PATIENT. A NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS A BELOW-THE-KNEE. THE TARGET VESSEL CHARACTERISTICS INCLUDED NO CALCIFICATION, NO TORTUOSITY, AND 35% 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 WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A LEAKAGE ON THE SHAFT OF THE SABER PTA BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873862 ↗
• MalfunctionMar 6, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE OPERATOR PLANNED TO USE A 3MM 15CM SABER BALLOON WHILE TREATING THE SUPERFICIAL FEMORAL ARTERY SEGMENT OF A MALE PATIENT SUFFERING FROM ATHEROSCLEROTIC OCCLUSIVE DISEASE OF THE LOWER LIMBS. WHILE PERFORMING VASCULAR PRE-DILATION, THE BALLOON RUPTURED. THE BALLOON WAS NOTED TO HAVE BURST AT 10 ATM. THE CASE WAS COMPLETED TO A NON-CORDIS BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE. 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 DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE SEVERE CALCIFICATION WITH MODERATE VESSEL TORTUOSITY. THE LESION WAS NOTED TO HAVE A STENOSIS OF MORE THAN 90%. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE BALLOON DID NOT KINK WHILE BEING USED. THE DEVICE WILL BE RETURNED FOR EVA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845038 ↗
• MalfunctionMar 13, 2023Leak/Splash; Leak/Splash

  AS REPORTED, RUPTURE WAS SUSPECTED AS THE BALLOON OF A SABER 3MM X 15CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER ENTERED THE LESION LOCATION IN PREPARATION FOR FILLING THE BALLOON FOR PRE-DILATION. ADDITIONAL INFORMATION PROVIDED CLARIFIED THAT IT WAS NOT A BURST. THE BALLOON WAS FOUND LEAKING WHEN THE CONTRAST WAS INFLATED INTO THE BALLOON AT ABOUT 10 ATM. THERE WAS A LITTLE BIT OF RESISTANCE/FRICTION WHILE INSERTING THE BALLOON INTO THE PATIENT. THE CONTRAST MEDIUM WAS FOUND TO FLOW IN THE VESSEL, AND THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY. FILLING OF THE BALLOON WAS ATTEMPTED OUTSIDE THE BODY TO CONFIRM A BALLOON RUPTURE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT UNDERWENT BALLOON DILATATION STENTOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY (SFA) IN THE RIGHT LOWER EXTREMITY. VESSEL CALCIFICATION WAS REPORTED MODERATE TO SEVERE. VESSEL TORTUOSITY WAS MILD TO MODERATE. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PERCENTAGE STENOSIS WAS ABOUT SEVENTY-FIVE (75) PERCENT. 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 US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530702 ↗
• MalfunctionApr 19, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 3MM 15CM 150 RUPTURED BELOW RBP DURING THE OPERATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR WHILE REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED TO THE DEVICE PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE INTENDED PROCEDURE WAS TO DILATE THE LESION WHICH HAD A STENOSIS. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE BALLOON CATHETER THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THE CATHETER ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND OR WAS NEVER KINKED WHILE BEING USED. THE INFLATION DEVICE USED WAS USED SUCCESSFULLY WITH OUT DEVICES. THE PRODUCT WAS REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). IT WAS NOTED THAT BALLOON WAS NOT IN A STENT WHEN IT RUPTURED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141118 ↗
• MalfunctionMay 10, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 3MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS RUPTURED. THEREFORE, IT FAILED TO BE EXPANDED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802505 ↗
• MalfunctionApr 18, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 3MM X 15CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PRE-DILATION; HOWEVER, THE BALLOON BURST WHEN PRESSURE PUMP WAS ABOUT 6 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. IT WAS REPLACED WITH A 3 X 150 SAVVY LONG AND 4 X 150 SAVVY LONG BALLOON CATHETERS AND A SMART STENT (UNKNOWN) WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT HAD LONG SEGMENT CALCIFIED OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) IN HIS LEFT LOWER EXTREMITY. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WERE USED WITH A ONE TO ONE RATIO. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THE RIGHT SFA WAS PUNCTURED THROUGH A NON-CORDIS GUIDEWIRE WITH A SINGLE CURVED CATHETER (UNKNOWN). THE DEVICE WILL BE RETURNED FOR EVALUATION. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THE GUIDE CATHETER. THE CATHETER HAS NEVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683432 ↗
• MalfunctionOct 15, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE 3MM X 15CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER BLASTED WHEN IT HITS THE WORKING PRESSURE THAT RESULTED IN THE OUTFLOW OF UNKNOWN CONTRAST AGENT, SO THE BALLOON DID NOT DILATE. WHEN INFLATED TO NOMINAL PRESSURE, THE CONTRAST LEAKED AND THE BALLOON DID NOT REMAIN INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NON CORDIS BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON DID NOT BURST; IT WAS A SLOW LEAKAGE. THE TARGET VESSEL WAS THE ANTERIOR TIBIAL ARTERY. THE VESSEL WAS MODERATELY CALCIFIED WITH NO TORTUOSITY, 30% STENOSIS, AND WAS A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR THE PROTECTIVE BALLOON COVER. THERE WAS NO 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 PREPPED NORMALLY. THE DEVICE WAS PREPPED WITH 50/50 CONTRAST/SALINE RATIO. THE DEVICE WAS INFLATED WITH A NON CORDIS INDEFLATOR AND THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683316 ↗
• MalfunctionJul 1, 2019Leak/Splash; Leak/Splash

  AS REPORTED, DURING THE OPERATION WHEN FILLING CONTRAST AGENT, LEAKAGE WAS NOTED FROM THE SABER (3 MM15 CM 150) BALLOON CATHETER. THE USER IMMEDIATELY STOPPED USING THE SABER AND IT WAS REPLACED WITH A NEW DEVICE TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8750899 ↗
• MalfunctionFeb 14, 2019Structural Problem; Structural Problem

  AS REPORTED, THE SABER 3MM15CM 150 BALLOON EXPANDED PAST THE MARKER BANDS. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS RECEIVED BY THE REPRESENTATIVE THE SAME MORNING OF THE PROCEDURE. 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 DEICE 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. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT 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 WAS THE ANTERIOR TIBIAL. THE DEVICE WILL NOT BE RETURNED FOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8340988 ↗
• MalfunctionDec 26, 2018Partial Blockage; Partial Blockage

  DURING USE IN PATIENT, IT WAS REPORTED THAT THE GUIDE WIRE CANNOT PASS THROUGH THE SABER BALLOON DELIVERY CAVITY, WHICH SEEMS TO BE BLOCKED BY THE DELIVERY CAVITY. DURING ANALYSIS OF THE DEVICE, A CROSS-SECTION CUTTING PROCEDURE WAS PERFORMED AND A FOREIGN MATERIAL WAS DETECTED THAT IMPEDED THE TRAVEL OF THE GUIDE WIRE INTO THE LUMEN. THERE WAS NO PATIENT INJURY. THE SAME WIRE WAS USED WITH ANOTHER CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE DEVICE WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REPORTED FLUSHING THE BALLOON CATHETER PRIOR TO USE. THERE WERE NO PROBLEMS NOTED DURING PREP. A NON-CORDIS GUIDEWIRE WAS USED WITH THE SABER BALLOON. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197405 ↗

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