SaberX Radianz R51006010LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032081303), received between Dec 20, 2019 and Jan 22, 2024 — classified as 1 injury, 2 malfunctions.

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

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.

• InjuryJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER INFLATION OF A 6MM X 10CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER OVER A NON-CORDIS GUIDEWIRE, THE DEVICE COULD NOT BE REMOVED DUE TO A LARGE ¿KNOT¿ FOUND ON THE GUIDEWIRE AND THE SABERX RADIANZ BALLOON CATHETER COULD NOT CROSS OVER THE KNOT TO EXIT THE PATIENT. FURTHER ATTEMPTS TO REMOVE THE SABERX RADIANZ BALLOON CATHETER WERE MADE, BUT THE SHAFT OF THE BALLOON CATHETER EVENTUALLY BROKE OFF OUTSIDE OF THE PATIENT. AS A RESULT, A SURGICAL CUT DOWN WAS PERFORMED IN ORDER TO REMOVE THE SABERX RADIANZ BALLOON CATHETER FROM THE KNOTTED NON-CORDIS GUIDEWIRE. A SECOND ACCESS POINT WAS MADE IN THE GROIN AND THE PROCEDURE WAS COMPLETED WITH A CONTINUOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) DRIP. THERE WERE NO PATIENT CONSEQUENCES. THIS WAS DURING A PROCEDURE TO TREAT A ¿COLD LEG¿ WHICH REQUIRED A TPA DRIP. THE SABERX RADIANZ BALLOON CATHETER WAS TO BE USED FOR ANGIOPLASTY OF THE MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS BEING USED WITH A SHORT CATHETER SHEATH INTRODUCER (CSI) AND WAS INSERTED FROM THE RADIAL ARTERY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553606 ↗
• MalfunctionApr 8, 2023Deflation Problem; Deflation Problem

  AS REPORTED, ALL THREE SABER X RADIANZ BALLOONS FAILED TO DEFLATE IN AN APPROPRIATE AMOUNT OF TIME. WITH ALL THREE BALLOONS IT TOOK 12 TO 15 SECONDS TO FULLY DEFLATE AND THE PHYSICIAN HAD TO PULL NEGATIVE THREE TIMES ON EVERY BALLOON, AFTER EVERY INFLATION, IN ORDER TO GET IT FULLY DEFLATED. ON COUPLE OF ATTEMPTS THE BALLOON DID NOT FULLY DEFLATE. ALSO, ONCE THE BALLOONS WERE REMOVED FROM THE BODY THEY COULD NOT BE REINSERTED AS THEY DID NOT EVER REWRAP. IT WAS FEARED THE LARGE, UNWRAPPED PROFILE OF THE USED BALLOON DISRUPT THE STENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705204 ↗
• MalfunctionDec 20, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM 10CM 155 SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INSERTED AND INFLATED, HOWEVER, THE PRESSURE WAS NOT ABLE TO RISE OVER 3 ATMOSPHERES (ATM). THEREFORE, IT WAS CONFIRMED THROUGH ANGIOGRAPHY THAT THE SALINE LEAKED FROM THE BALLOON CATHETER. THE TARGET LESION WAS SUPERFICIAL FEMORAL ARTERY (SFA) WITH STENOSIS. A 6F UNKNOWN SHEATH INTRODUCER AND 0.14 UNKNOWN GUIDEWIRE WERE USED. THE SABER RX CATHETER WAS REPLACED WITH ANOTHER 6MM NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION HAD MODERATE CALCIFICATION AND MODERATE VESSEL TORTUOSITY. THERE WAS 90% STENOSIS. THE DEVICE WAS NOT USED FOR CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED NORMALLY MAINTAINING NEGATIVE PRESSURE ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO KIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504584 ↗