SABER 48005010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032068625), received between Jan 5, 2018 and Aug 28, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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.

• MalfunctionAug 28, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MM X 10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER RUPTURED AT EIGHT (8) ATMOSPHERES (ATM). AN ALTERNATIVE SABER WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. A NON-CORDIS 0.014 GUIDEWIRE WAS USED FOR SUPPORT IN THE VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) AND PASSED. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, COULD NOT BE OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633441 ↗
• MalfunctionJun 23, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AN IMAGE WAS PROVIDED FOR REVIEW. THIS WAS AN IMAGE OF A REMAINING BALLOON WHICH WAS AT THE PROXIMAL TO THE FOREARM ARTERIOVENOUS (AV) SHUNT ANASTOMOSIS. THE PICTURE PROVIDED HAS AN OPERATOR'S ARM ACROSS IT. THE PICTURE WAS TAKEN PRIOR TO THE CUTDOWN AND REMOVAL OF THE PORTION LEFT BEHIND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191928 ↗
• MalfunctionOct 5, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM 10CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED. THEREFORE, IT WAS REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE SABER PTA WAS USED FOR PRE-DILATION. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627740 ↗
• MalfunctionSep 2, 2020Material Rupture; Material Rupture

  A 5MM X 10CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN NOMINAL PRESSURE DURING USE FOR A SHUNT PTA CASE. THEREFORE, IT WAS REPLACED WITH ANOTHER UNKNOWN BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND FLUSHED AS PER INSTRUCTION FOR USE (IFU). THE 99% OCCLUDED LESION HAD SEVERE VESSEL TORTUOSITY. IT WAS NOT CONSIDERED A CHRONIC TOTAL OCCLUSION (CTO). THE ACCESS SITE WAS THE RADIAL ARTERY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE FORMING TUBE, NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH FROM THE NEEDLE AND NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL, NO DIFFICULTY CROSSING THE LESION AND THE CATHETER WAS NEVER IN AN ACUTE BEND. T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10483378 ↗
• MalfunctionJan 5, 2018Leak/Splash; Leak/Splash

  DURING PREP, IT WAS REPORTED THAT THE SABER BALLOON CATHETER WAS LEAKING. THE DEVICE WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. A SABER PTA WAS PREPARED AND AIR WAS REMOVED. HOWEVER THE AIR CONTINUOUSLY RELEASED AND COULD NOT COMPLETED AIR PURGE. THE PHYSICIAN ATTEMPTED TO INFLATE THE SABER PTA OUTSIDE THE PATIENT, AND A LEAKAGE FROM THE BALLOON WAS CONFIRMED. THE TARGET LESION WAS THE SHUNT. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167944 ↗

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