SABER 48002025XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032069226), received between Apr 16, 2021 and May 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, THE 2MM X 250MM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS USED TO PRE-DILATE AND THE BALLOON WAS NOT ABLE TO BE INFLATED. THERE WAS A LITTLE RESISTANCE FOUND WHEN REMOVING THE DEVICE FROM THE PATIENT, BUT IT WAS REMOVED INTACT (IN ONE PIECE) AND REPLACED WITH ANOTHER BALLOON AND WAS USED WITH NO PROBLEM. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS USED TO TREAT A LOWER EXTREMITY OCCLUSION. THERE WERE NO DAMAGES FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR ANY OF THE STERILE PACKAGING COMPONENTS. THE TARGET SITE WAS 90% STENOSED. THE ACCESS SITE WAS NORMAL. THE DEVICE DID NOT MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE. THE DEVICE WAS ABLE TO CROSS THE LESION AND DID NOT KINK AT ANY TIME DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY. THE BALLOON DID NOT LEAK FROM ANY SEGMENT. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957559 ↗
• MalfunctionFeb 2, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE PATIENT WAS IN THE ENDOCRINOLOGY DEPARTMENT WITH A DIABETIC FOOT, HAVING BALLOON DILATATION WAS PROPOSED. SURGICAL DILATATION WAS PERFORMED USING 2MM 25CM SABER; HOWEVER, THE BALLOON WAS FOUND TO BE RUPTURED AND THE CONTRAST AGENT OOZED OUT. THE BALLOON WAS REPLACED AND DILATATION WAS PERFORMED WITHOUT ANY ABNORMALITY IN THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, BOTH WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634349 ↗
• MalfunctionApr 16, 2021Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 2MM X 25CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER HAD LEAKAGE AND FAILED TO BE INFLATED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, WHEN REMOVING THE PROTECTIVE BALLOON COVER OR WHEN 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 CONTRAST TO SALINE RATIO WAS 1:1. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. VESSEL /LESION CHARACTERISTICS: THE LESION HAD CALCIFICATION, NO VESSEL TORTUOSITY. , THE VESSEL WAS 90% STENOSED . THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN ACUTE BEND. THE PLUNGER DID DEPRESS INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE USER WAS ABLE TO DEPRESS THE PLUNGER INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE MAXIMUM INFLATION PRESSURE WAS ZERO. THE DEVICE WIL

  Patient problems: Insufficient Information

  MAUDE report 11678682 ↗

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