SABER 48006004XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032068175), received between Feb 15, 2018 and Dec 24, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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.

• MalfunctionDec 24, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE 6MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING DILATION, AND THE PROXIMAL SEGMENT FRACTURED/SPLIT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU. THERE WERE NO DIFFICULTIES REMOVING IT FROM THE HOOP, BALLOON COVER, OR STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGE WERE OBSERVED BEFORE INSERTION, AND THE DEVICE WAS PREPARED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE INTENDED PROCEDURE INVOLVED RUPTURE OF THE FENESTRATION MEMBRANE IN A THORACIC AORTIC STENT. THE VESSEL SHOWED NO CALCIFICATION, TORTUOSITY, OR STENOSIS, AND THE DEVICE WAS NOT USED FOR CHRONIC TOTAL OCCLUSION. NO RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, NOR WHEN ADVANCING THE BALLOON OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND, AND THE BALLOON DID NOT KINK DURING USE. A 1:1 CONTRAST-TO-SALINE RATIO WAS USED. THE PROCEDURE WAS COMPLETED USING A BACKUP NON-CORDIS BALLOON. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888515 ↗
• InjuryJun 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE USER FELT RESISTANCE WHEN TRYING TO REMOVE THE SABER 6MM 4CM BALLOON FROM THE NON-CORDIS SHEATH AND OVER A NON-CORDIS .018 WIRE. THE BALLOON WAS CAUGHT UP ON THE DISTAL END OF THE SHEATH. WHEN TRYING TO PULL OUT OF SHEATH, A PIECE OF THE BALLOON RIPPED OFF AND TRAVELED DOWN TO THE GENICULATE ARTERY WHERE THE TEAM WAS UNABLE TO RETRIEVE. THE PHYSICIAN TRIED TO SNARE THE PIECE OF BALLOON BUT WAS UNSUCCESSFUL. BALLOON IS STILL IN THE PATIENT. THE ACCESS SITE WAS IN THE COMMON FEMORAL ARTERY WITH NO CALCIUM OR TORTUOSITY NOTED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION REGARDING THE RETURNED DEVICE WAS REQUESTED; HOWEVER, INFORMATION WAS NOT OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107655 ↗
• MalfunctionMay 3, 2022Crack; Crack

  AS REPORTED, PRIOR TO ENTERING THE PATIENT, THE DISTAL TIP OF A 6MM X 4CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND TO BE FRACTURED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE TIP OF THE BALLOON DID NOT EMBOLIZE AND THERE WAS NO NEED FOR RETRIEVAL OF ANY PART OF THE DEVICE AS THE DEVICE WAS NEVER USED INSIDE OF THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268766 ↗
• MalfunctionApr 18, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING A SLOW INFLATION OF A 6MM X 4CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO 3 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A STENOSIS OF AN UNKNOWN VESSEL. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). 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. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED AS THE DEVICE WAS INSERTED INTO THE PATIENT. THE DEVICE WAS ABLE TO ADVANCE AND CROSS THE LESION WITH EASE, IT WAS NEVER IN AN ACUTE BEND, AND THE DEVICE DID NOT KINK DURING THE PROCEDURE. AFTER THE RUPTURE OCCURRED, THE BALLOON CATHETER WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE. INFORMATION REGARDING THE TARGET LESION, PERCENTAGE OF STENOSIS, CONTRAST USED, CONTRAST TO SALINE RATIO, AND THE COMPLETION OF THE PROCEDURE WAS REQUESTED BUT NOT PROVIDED, AND THE DEVICE WILL BE RETUNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14134742 ↗
• MalfunctionJun 16, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MMX4CNX150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER WAS INFLATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) ORIGIN AND POPPED. THE USER WAS UNABLE TO DEPRESS THE PLUNGER INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE BALLOON DID NOT INFLATE NORMALLY, THE LEAKAGE WAS NOTED FROM THE BALLOON, SHAFT, HUB, OR UNKNOWN SEGMENT. THE BALLOON DID NOT MAINTAIN PRESSURE DURING INFLATION. THE BALLOON BURST. THE SHAFT DID NOT BURST THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR WHEN REMOVING THE PROTECTIVE BALLOON COVER. ALSO 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 OR PRODUCT INTO THE PATIENT. THE DEVICE DID PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 30/70. A NON CORDIS INFLATION DEVICE WAS USED AND THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. VESSEL / LESION CHARACTERISTICS; THE LESIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011157 ↗
• MalfunctionSep 17, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 4MM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS IN A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) AND THEN POPPED DURING INFLATION. THEREFORE, ANOTHER 6MM X 4MM SABER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE USER WAS TRAINED WITH THE DEVICE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE VESSEL LEVEL OF CALCIFICATION IS SEVERE. THE VESSEL LEVEL OF ANGULATION AND TORTUOSITY IS MILD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMAL. THE CONTRAST TO SALINE RATIO WAS 30/70. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON INFLATED NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS 16-ATMOSPHERES PRESSURE (ATM). THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10546979 ↗
• MalfunctionMay 30, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER PTA BALLOON CATHETER (6MM4CM 150) WAS INSERTED AND RUPTURED AT 8-ATMOSPHERES PRESSURE (ATM) DURING ITS INITIAL INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THE SABER PTA BALLOON WAS REPLACED WITH A NEW SABER PTA BALLOON (6MM, 10CM) AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WITH ISO. THE VESSEL LEVEL OF ANGULATION, CALCIFICATION AND TORTUOSITY IS NONE. INITIALLY, A CONTRALATERAL APPROACH WAS MADE WITH A 6F NON-CORDIS GUIDE SHEATH. THEN, A NON-CORDIS GUIDEWIRE WAS INSERTED AND CROSSED THE LESION. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50:50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON RUPTURED AFTER INFLATED. THERE WAS NO LEAKAGE NOTED FROM THE BALLOON, SHAFT, HUB, OR UNKNOWN SEGMENT. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE IS NO PROCEDURAL FILM/CD AVAILABLE FOR REVIEW. THE DEVICE WILL BE RETURNED FOR A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656015 ↗
• MalfunctionFeb 15, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE SABER BALLOON CATHETER RUPTURED AT TEN ATMOSPHERE (10 ATM). THERE WAS NO REPORTED PATIENT INJURY. THE SABER BALLOON WAS REPLACED WITH A SAME SIZE NEW NON CORDIS BALLOON CATHETER, A STENT WAS THEN IMPLANTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A GUIDEWIRE CROSSED THE LESION AND A SABER BALLOON WAS DELIVERED TO THE LESION FOR PRE DILATATION. HOWEVER, IT RUPTURED AT APPROXIMATELY 10 ATM DURING ITS INITIAL INFLATION. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS 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 7273372 ↗

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