SABER 48002010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032068359), received between Apr 21, 2017 and Oct 4, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THIS WAS A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE, A SABER 2MM10CM 90 WAS USED FOR PRE- PLAIN OLD BALLOON ANGIOPLASTY (POBA); HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE. THERE WERE NO REPORTED PATIENT INJURIES. THE SABER WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU), IT WAS INSERTED, CROSSED THE LESION AND ATTEMPTED TO PERFORM POBA. THE SABER WAS REPLACED WITH A NEW BALLOON CATHETER AND POBA WAS COMPLETED. THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9158287 ↗
• MalfunctionMar 13, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER 2MM10CM90 RUPTURED WITHIN ITS RATED BURST PRESSURE. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS REPLACED WITH A DIFFERENT SIZE NEW SABER BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418329 ↗
• MalfunctionApr 21, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED, DURING DEFLATION, THAT THE SABER 2 MM 10 CM 90 BALLOON CATHETER WAS LEAKING FLUID. THERE WAS NO PATIENT INJURY.  THE FLUID THAT CAME OUT OF THE BALLOON WAS GREEN COLORED. THIS OCCURRED 2 TIMES ALREADY. CUSTOMER WOULD LIKE TO KNOW THE REASON AND WHERE THE COLOR COMES FROM. SABER BALLOON HAS BEEN INTACT SO FAR. BALLOON IS NOT AVAILABLE. BUT THE LIQUID AND THE INFLATION DEVICE ARE AVAILABLE FOR TESTING AND WILL BE RETURNED. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DIFFICULTY NOTED. THE DEVICE DIDN'T LEAKED DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR 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 PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. SOLUTRAST 200 IS THE CONTRAST MEDIA USED WITH A 50:50 SAINE RATIO. A MERIT MEDIAL INFLATOR DEVICE WAS USED; WHICH WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, GUIDE CATHETER, OR ADVANCING THE BALLOON CATHETER THROU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6513154 ↗

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