SABER 48007006SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032068854), received between Jan 14, 2019 and Aug 24, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionAug 24, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, A 7MM X 6CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER POPPED WHILE INFLATED WITHIN AN ARTERIOVENOUS (AV) FISTULA GRAFT. THERE WAS SOME DIFFICULTY ADVANCING THE CATHETER THROUGH THE BLOOD VESSEL AND SOME DIFFICULTY CROSSING THE LESION. THE PROCEDURE WAS COMPLETED BY REMOVING THE BALLOON AND USING ANOTHER UNKNOWN BALLOON CATHETER SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD. THE USER WAS TRAINED WITH THE DEVICE. THE FISTULA HAD NO CALCIFICATION, NO TORTUOSITY, AND 90% STENOSIS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING 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 DEVICE PREPPED NORMALLY. A CONTRAST:SALINE RATIO OF 50:50 WAS USED. A NON CORDIS INDEFLATOR WAS USED AND IT WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PLUNGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358617 ↗
• InjuryJul 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE SABER (7MM6CM 90) BALLOON TIP CAME OFF THE CATHETER WHILE ADVANCING BALLOON INTO PATIENT. THE PRODUCT WAS CLINICALLY USED AND WAS DISCARDED. THE INTENDED PROCEDURE WAS A PLAIN OLD BALLOON ANGIOPLASTY (POBA). THE ACCESS SITE WAS THE FEMORAL ARTERY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WITH IT HAD NOT BEEN RESTERILIZED. THERE WAS NO DIFFICULTY TRACKING THE DEVICE THROUGH THE VESSEL TO GET TO THE LESION. THERE WAS NO DIFFICULTY CROSSING THE LESION. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. 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. RESISTANCE WAS NOT MET WHILE WITHDRAWING THE DEVICE. THE DEVICE SEPARATED APPROXIMATELY 3CM FROM THE DISTAL END. THERE WERE NO OTHER ANOMALIES NOTED WHEN THE D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780752 ↗
• MalfunctionJan 14, 2019Leak/Splash; Leak/Splash

  AS REPORTED, THE SHAFT OF A SABER BALLOON CATHETER HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SABER PTA BALLOON CATHETER. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR PROTECTIVE BALLOON COVER. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE. THERE WAS UNUSUAL FORCE USED DURING THE PROCEDURE. CONTRAST LEAKED OUT OF THE CATHETER. THE BALLOON WAS STILL ABLE TO BE INFLATED, DESPITE THE LEAK IN THE CATHETER. THERE ARE NO PROCEDURAL FILMS OR CD¿S AVAILABLE FOR REVIEW. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246168 ↗

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