SABER 48004015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20705032069486), received between Jan 22, 2019 and Sep 12, 2025 — classified as 1 injury, 12 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. How this data works · Data updated Oct 13, 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 4MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO 12 ATMOSPHERES (ATM), NO BALLOON EXPANSION WAS OBSERVED. SUBSEQUENT ASPIRATION OF THE BALLOON REVEALED BLOOD WITHIN THE PRESSURE PUMP, 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 LEFT LOWER LIMB POPLITEAL ARTERY LESION. THE TARGET VESSEL HAD MODERATE CALCIFICATION, MILD TORTUOSITY, AND 80% STENOSIS. AN UNKNOWN .018 GUIDEWIRE WAS 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). THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING, AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038833 ↗
• MalfunctionMay 12, 2024Leak/Splash; Leak/Splash

  AS REPORTED, A 4MM 15CM .018 SABER PTA BALLOON WAS PUT INTO THE PATIENT FOR STANDARD BALLOONING OF THE SFA ARTERY. UPON INFLATION, THE BALLOON WAS NOT INFLATING FULLY, AND THE DOCTOR NOTED THAT HIS INDEFLATOR/INFLATION DEVICE WAS UNABLE TO HOLD PRESSURE, LEADING HIM TO BELIEVE THE BALLOON WAS BROKEN/HAD A TEAR OR HOLE SOMEWHERE. THE REST OF THE CASE WAS FINISHED WITH MORE CORDIS SABER .018 BALLOONS OF DIFFERENT SIZES, WITH NO ISSUES WITH FURTHER SAID BALLOONS, OR ANY OF THE OTHER EQUIPMENT USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE 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 LESION WAS NOTED TO HAVE LITTLE CALCIFICATION. THE VESSEL DID NOT HAVE ANY TORTUOSITY. 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 A BALLOON THROUGH THE GUIDE

  Patient problems: Complete Neonatal Hearing Loss

  MAUDE report 19295973 ↗
• MalfunctionJun 29, 2023Deflation Problem; Deflation Problem

  AS REPORTED, DURING THE USE OF A 4MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON WAS UNABLE TO BE DEFLATED. UPON REMOVAL OF THE DEVICE, THERE WAS A CRACK OBSERVED ON THE INFLATION HUB. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WAS ABLE TO BE REMOVED IN ONE PIECE FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17230015 ↗
• MalfunctionJun 28, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE INFLATION OF A 4MM X 15CM 50CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, CONTRAST WAS OBSERVED LEAKING INTO THE DISTAL VESSEL UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE DEVICE WAS REMOVED AND INFLATED ONCE MORE OUTSIDE OF THE PATIENT WHICH REVEALED THAT THE BALLOON HAD RUPTURED AT THE DISTAL TIP AS ¿PHYSIOLOGICAL SALINE WAS EJECTED IN A WATER COLUMN.¿ A NEW 4MM X 15CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO DILATE THE LESION, AND AN UNKNOWN DRUG COATED BALLOON (DCB) WAS USED. THE DEVICES WERE WITHDRAWN, AND AN EXOSEAL 6F VASCULAR CLOSURE DEICE (VCD) WAS USED TO ACHIEVE HEMOSTASIS AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT LEFT FEMORAL ARTERY STENOSIS IN WHICH AN APPROACH FROM THE RIGHT FEMORAL ARTERY WAS MADE WITH A NON-CORDIS 6F CATHETER SHEATH INTRODUCER (CSI). THE LESION WAS CALCIFIED. A 4F CORDIS MULTIPURPOSE (MPA) CATHETER WAS USED DURING THIS PROCEDURE AND THE INITIAL 4MM X 15CM SABER PTA BALLOON CATHETER WAS DELIVERED TO THE LESION OVER A NON-CORDIS .018 GUIDEWIRE. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER INSTRUCTIONS FOR USE (IFU) AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215527 ↗
• MalfunctionMay 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER 4*150MM WAS USED FOR A SECOND DILATION. WHEN THE BALLOON WAS FILLED WITH THE PRESSURE PUMP, THE PRESSURE STARTED TO DROP AT 12 ATM AND NEVER COMPLETED FILLING. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. AFTER REMOVING THE BALLOON AND TRYING TO FILL IT OUTSIDE THE BODY, THE OPERATOR FOUND THAT THE BALLOON HAD A RUPTURE OF THE HOLE MOUNT AFTER. THE LESION WAS RE-EXPANDED WITH A NEW BALLOON UNTIL THE DCB WAS TREATED WITH POST-IMAGING, AND THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT RETURNED TO THE WARD. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT'S LOWER EXTREMITY ARTERY WAS OCCLUDED, AND THE SURGICAL PLAN WAS PTA+DCB TO THE SUPERFICIAL FEMORAL ARTERY SEGMENT. THE RIGHT FEMORAL ARTERY WAS PUNCTURED AND AN UNKNOWN 6F SHORT SHEATH WAS PLACED. A NON-CORDIS .035 GUIDEWIRE WAS USED WITH A 5F C2 CATHETER TO GET TO THE LEFT ILIAC ARTERY. THIS WAS FOLLOWED BY WITHDRAWAL OF THE CATHETER AND SHORT SHEATH, AND AN UNKNOWN 6F OVERTURNING SHEATH WAS PLACED WITH THE GUIDEWIRE. A 4F MPA ANGIOGRAPHIC CATHETER WAS PLACED IN THE LEFT SUPERFICIAL FEMORAL ARTERY AND ANGIOGRAPHY WAS PERFORMED, SHOWING OCCLUSION OF THE LONG SEGMENT FROM THE MID-SUPERFICIAL FEMORAL TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860512 ↗
• InjuryOct 7, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, A 4MM X 15CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST EXPLOSIVELY AT 6-7 ATMOSPHERES (ATM). THE SABER WAS THEN PULLED BACK; HOWEVER, IT GOT STUCK TO THE GUIDEWIRE (UNKNOWN). BOTH GUIDEWIRE (UNKNOWN) AND THE SABER WERE PULLED PARTIALLY BACK INTO THE NON-CORDIS SHEATH. THE NON-CORDIS SHEATH, WITH BOTH THE SABER AND THE GUIDEWIRE (UNKNOWN) WERE PULLED BACK INTO THE IPSILATERAL SIDE. AFTER REMOVING FROM THE PATIENT, IT SHOWED THAT ONE MARKER AND SOME PIECES FROM THE BALLOON MATERIAL WERE LEFT INSIDE THE PATIENT. THEREFORE, A STENT (UNKNOWN) WAS PLACED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO PREVENT THE MATERIAL FROM MOVING DISTALLY. THE SABER WAS USED BELOW THE KNEE. THE OPERATOR WAS TRAINED TO USE THE DEVICE. THE LESION HAD LITTLE TO NO CALCIFICATION. THERE VESSEL HAD LITTLE TO NO TORTUOSITY. 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

  Patient problems: Foreign Body In Patient

  MAUDE report 12588438 ↗
• MalfunctionJul 23, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, ON THE FIRST BALLOON DILATION OF A 4MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, A BALLOON BURST WAS OBSERVED AT 10CM FROM THE DISTAL PART OF THE BALLOON. THE BALLOON RUPTURE OCCURRED AT A SEVERELY CALCIFIED STENOTIC LESION (IT RUPTURED AT 12 ATMOSPHERES). THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE DEVICE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE BURST OCCURRED AT THE DISTAL END. THE DEVICE WAS PREPPED NORMALLY, AND NEGATIVE PRESSURE WAS MAINTAINED. THE TARGET LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION HAD LITTLE TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE DEVICE WAS INSERTED INTO HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE THE DEVICE WAS BEING INSERTED THROUGH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218596 ↗
• MalfunctionApr 20, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  THERE WAS DIFFICULTY ADVANCING A 4MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER THROUGH THE VESSEL AND DIFFICULTY CROSSING THE LESION. IT COULD NOT BE INFLATED BECAUSE THE BALLOON WAS BROKEN. IT WAS REPLACED WITH SABER (4X100, 5X150) AND EXPANDED STEP BY STEP, AND A SMART STENT WAS IMPLANTED TO COMPLETE THE OPERATION. ANALYSIS OF THE RETURNED DEVICE INDICATED BALLOON SEPARATION CAUSED BY A RUPTURE ON THE BALLOON SURFACE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD A RIGHT LOWER EXTREMITY SUPERFICIAL FEMORAL ARTERY LONG SEGMENT 100% CHRONIC TOTAL OCCLUSION (CTO) WITH NO VESSEL TORTUOSITY. A LEFT FEMORAL ARTERY PUNCTURE WAS DONE AND A 6F UNKNOWN SHEATH WAS PLACED. A V18 GUIDEWIRE (NON-CORDIS) WAS USED TO OPEN THE RIGHT LOWER EXTREMITY SUPERFICIAL FEMORAL ARTERY OCCLUSION SEGMENT. THERE WAS NO DIFFICULTY REMOVING THE PACKAGING COMPONENTS AND NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THERE WAS A 1:1 CONTRAST TO SALINE RATIO WITH THE INDEFLATOR. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694829 ↗
• MalfunctionApr 17, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM 15CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WHEN WORKING PRESSURE HITS EIGHT (8) ATMOSPHERES (ATM). THE BALLOON PULLED OUT AS A WHOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS MODERATELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 90%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE DEVICE WAS PREPPED NORMALLY. A NON-CORDIS CONTRAST MEDIA WAS USED. THE CONTRAST TO SALINE RATIO WAS 1:1. A NON-CORDIS INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971960 ↗
• MalfunctionNov 1, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A 0.018CM GUIDEWIRE FAILED TO GO THROUGH THE 4MM X 15CM X 150 SABER BALLOON CATHETER AFTER THEY BOTH HAD BEEN DELIVERED TO THE LESION. THEREFORE, THE SABER WAS REPLACED WITH ANOTHER BALLOON OF THE SAME BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. INITIALLY, THE LOWER EXTREMITY VEIN WAS OPENED AND THE GUIDEWIRE CROSSED THE LESION. THE BALLOON WAS INTENDED TO BE USED TO EXPAND THE LESION. THE PACKAGE OF THE BALLOON WAS NOT DAMAGED. THE PACKAGE WAS OPENED, THE BALLOON REMOVED AND THE NECESSARY STEPS FOR FLUSHING AND EXHAUST WERE MADE. ADDITIONAL INFORMATION WAS RECEIVED AFTER PRELIMINARY PRODUCT EVALUATION, A .018¿ GUIDE WIRE SAMPLE WAS INTRODUCED INTO THE GUIDE WIRE LUMEN OF THE SABER BALLOON VIA TIP. THE SAMPLE GUIDE WIRE COULD NOT BE ADVANCED THROUGH THE GUIDE WIRE LUMEN DUE TO A RUPTURE IN IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267104 ↗
• MalfunctionAug 26, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING A LOWER EXTREMITY ARTERY SURGERY, THE NON-CORDIS GUIDEWIRE CAN NOT BE WITHDRAWN BY USING THE 4MM X 15CM 150 SABER BALLOON CATHETER. THE DEVICE COULD NOT BE WITHDRAWN AFTER EXPANSION, SO THE GUIDEWIRE AND THE BALLOON WERE WITHDRAWN TOGETHER. PER PRODUCT EVALUATION OF THE RECEIVED DEVICE, THE OUTER BODY PRESENTS A HOLE 5 CM FROM THE PROXIMAL MARKER BANDS. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO RESISTANCE/FRICTION BETWEEN THE DEVICES. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION HAD SEVERE CALCIFICATION AND THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE DID PREP NORMALLY. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING 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 INTO THE PATIENT. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. OTHER PRODUCTS WERE SUCCESSFULLY USED WITH THE DEVICE PRIOR TO T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932056 ↗
• MalfunctionFeb 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF A SABER BALLOON CATHETER (4MM, 15CM, 150) FELL OFF DURING PREP. THE DEVICE WAS NOT CLINICALLY USED AND THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS OPENED IN A STERILE FIELD AND STORED AS PER LABELING. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU. THE DEVICE DID NOT PREP NORMALLY; THE TIP FELL OFF WHEN INJECTING SALINE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8348349 ↗
• MalfunctionJan 22, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER BALLOON CATHETER (4MM15CM 150) WAS BEING USED FOR PRE-DILATION, HOWEVER, IT RUPTURED AT 10 ATMOSPHERES (ATMS) AFTER 30 SECONDS DURING IT¿S SECOND INFLATION. THE DEVICE WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER TO COMPLETE THE PROCEDURE. INITIALLY, AN IPSILATERAL APPROACH WAS MADE TO THE LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY USING A NON-CORDIS GUIDING SHEATH AND THE LESION WAS CROSSED USING A NON-CORDIS GUIDEWIRE. THE LESION WAS DESCRIBED AS HAVING SEVER CALCIFICATION AND STENOSIS. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND HAS BEEN DISCARDED BY MISTAKE, SO WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8267887 ↗

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