SABER 48002010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032069059), received between Jul 29, 2020 and Jul 25, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 2MM 10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED UPON LOW INFLATION. A NEW BALLOON WAS OPENED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610326 ↗
• MalfunctionFeb 20, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 2MM 10CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND TO HAVE RUPTURED. THEREFORE, AFTER REMOVING THE SABER PTA, THE PROCEDURE WAS PERFORMED USING ANOTHER SABER PTA PRODUCT OF THE SAME SIZE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER NOR REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREP NORMALLY. THE INTENDED PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS A LITTLE CALCIFIED AND TORTUOUS. THERE WAS 20% OF STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL NOR CROSSING THE LESION. AN UNKNOWN INDEFLATOR DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406225 ↗
• MalfunctionOct 14, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING PREPARATION OF A 2MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE DEVICE WAS UNABLE TO MAINTAIN NEGATIVE PRESSURE, AND A LEAKAGE WAS OBSERVED ON THE BALLOON OF THE DEVICE. AS A RESULT, THE DEVICE WAS NOT USED IN THE PATIENT, AND FIVE NON-CORDIS BALLOON CATHETERS WERE USED WITHOUT ISSUE TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING PROCEDURE TO TREAT AN 85% STENOSED LESION IN THE ILIAC VEIN. THE LESION DID NOT HAVE ANY CALCIFICATION OR VESSEL TORTUOSITY. THE 2MM X 10CM SABER PTA BALLOON CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND A 1:1 CONTRAST TO SALINE RATIO WAS USED TO PREP THE BALLOON. OTHER THAN THE BALLOON LEAKAGE, THERE WERE NO KINKS OR DAMAGES OBSERVED DURING THE PREPARATION OF THE SABER PTA BALLOON CATHETER. AFTER THE LEAKAGE WAS OBSERVED, A 2MM X 15CM NON-CORDIS BALLOON CATHETER WAS USED, FOLLOWED BY THE USE OF A 4MM X 15CM NON-CORDIS BALLOON CATHETER, A 6MM X 15CM NON-CORDIS BALLOON CATHETER, A 10MM X 15CM NON-CORDIS BALLOON CATHETER, AND A 12MM X 15CM NON-CORDIS BALLOON CATHETER. THERE WERE NO ISSUES WITH THE 5 NON-CORDIS BALLOON CATHETERS THAT WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611940 ↗
• MalfunctionAug 23, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHILE USING A 2MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON COULD NOT BE INFLATED. AFTER REMOVING THE SABER PTA BALLOON CATHETER, A PINHOLE RUPTURE WAS OBSERVED ON THE BALLOON. AS A RESULT, THE SABER PTA BALLOON CATHETER WAS REPLACED WITH A 2MM X 10MM NON-CORDIS BALLOON CATHETER WHICH WAS USED WITHOUT ISSUE TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN INTVENTIONAL PROCEDURE TO TREAT A LESION IN THE TIBIAL ARTERY WHICH HAD AN 80% STENOSIS AND WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE LESION HAD MILD CALCIFICATION, BUT NO VESSEL TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A 1:1 CONTRAST TO SALINE RATIO WAS USED TO PREP THE BALLOON. 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 DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO TRACK TOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274846 ↗
• MalfunctionJul 29, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 2MM X 10CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER SHOWED A GRADUAL FALL ON ITS PRESSURE VALUE UNDER THE PERSPECTIVE OF DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). INITIALLY, THE BALLOON HAD REACHED THE WORKING PRESSURE OF 8 ATMOSPHERES (ATM). THE DOCTOR PERFORMS REPEATED ATTEMPTS TO FILL BUT STILL INEFFECTIVE. THEREFORE, THE SABER PTA WAS REPLACED WITH A NON-CORDIS BALLOON AND APPLIED THE SAME PRESSURE VALUE, THE DOCTOR HAD SUCCESSFULLY DILATED THE LESIONS. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS INTERVENTIONAL. THE INTENDED VESSEL WAS THE "LOWER LIMB ARTERY". THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. THE LESION WAS CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 99%. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO) (TOTAL OCCLUSION >3 MONTHS). THE PATIENT HAS A RIGHT SUB-KNEE ARTERIOSCLEROSIS OCCLUSIONS. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. CONTRAST WITH A 1:1 SALINE RATIO WAS USED. A NON CORDIS INFLATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10337357 ↗

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