SABER 48003020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032069110), received between Sep 30, 2019 and Aug 11, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212698 ↗
• MalfunctionSep 16, 2025Leak/Splash; Leak/Splash

  AS REPORTED, AFTER ADVANCING THE 3X200 SABER PERCUTNEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON INTO THE VESSEL AND APPLYING PRESSURE. THE BALLOON COULD NOT INFLATE PROPERLY. AFTER ANOTHER ATTEMPT TO PRESSURIZE, LEAKAGE WAS FOUND IN THE BALLOON. THE BALLOON WAS THEN WITHDRAWN, AND ANOTHER BALLOON OF THE SAME MODEL WAS USED TO CONTINUE THE PROCEDURE. NO OTHER SERIOUS ADVERSE OUTCOMES OCCURRED. THIS OCCURRED DURING A BELOW-THE-KNEE ARTERY PTA PROCEDURE. A 2.5X300 SABER PTA BALLOON WAS USED FIRST, WHICH WENT SMOOTHLY. THE 3X200 PTA BALLOON WAS USED FOR STEPWISE DILATATION. THE PRODUCT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO ISSUES WERE NOTED DURING REMOVAL FROM THE HOOP, PROTECTIVE COVER, OR STERILE PACKAGING. NO DAMAGE OR KINKS WERE OBSERVED PRIOR TO INSERTION. THE INTENDED PROCEDURE WAS FOR A BELOW-THE-KNEE VESSEL OCCLUSION. THE LESION WAS MODERATELY CALCIFIED, MILDLY TORTUOUS, AND HAD A STENOSIS OF APPROXIMATELY 65¿75%. THE DEVICE WAS USED FOR TREATING A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO DIFFICULTIES ADVANCING THE BALLOON THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT PLACED IN AN ACUTE BEND. THE CONTRAST TO SALINE RATIO US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064499 ↗
• MalfunctionMay 30, 2025Leak/Splash; Leak/Splash

  AS REPORTED, A LEAKAGE WAS FOUND FROM THE BALLOON OF A 3MM X 20CM X 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER DURING DILATATION OF THE POPLITEAL ARTERY. THERE WAS NO REPORT OF SERIOUS INJURY. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117617 ↗
• InjurySep 30, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE SABER (3MM20CM 150) BALLOON CATHETER WAS LOST FROM THE SHAFT INSIDE OF THE PATIENT. THE HEALTH CARE PRACTITIONER GRABBED SUCCESSFULLY THE LOST BALLOON AND BROUGHT IT OUTSIDE OF THE PATIENT. RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE. NO INJURIES TO THE PATIENT OCCURRED AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE INTENDED PROCEDURE/TARGET LESION WAS THE PTA POPLITEAL ARTERY. THE LESION WAS MODERATELY CALCIFIED. THERE WAS NO TORTUOSITY OR VESSEL ANGULATION. THE PERCENTAGE OF STENOSIS WAS 80%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. RESISTANCE WAS NOT MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUING WAS NOT REQUIRED. RESISTANCE WAS NOT MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135615 ↗

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