SABERX .014 PTA Dilatation Catheter 47520300MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032086988), received between Apr 21, 2025 and Aug 4, 2025 — classified as 1 injury, 2 malfunctions.

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

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.

• MalfunctionAug 4, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 2MM X 300MM SABER .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST DURING INFLATION TO 10 ATMOSPHERES (ATM). THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS THE RIGHT POSTERIOR TIBIAL (PT). THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED MODERATE CALCIFICATION, MILD TORTUOSITY, AND 90% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706038 ↗
• InjuryJul 7, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE 2.0 X 300 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING IPSILATERAL BELOW THE KNEE (BK) TREATMENT. THE LESION WAS A BYPASS RESTENOSIS. A 4.5F NON-CORDIS SHEATH WAS USED WITH A NON-CORDIS .014 GUIDEWIRE (GW). THE GW CROSSED EASILY, THE SABERX DELIVERED AND EXPANDED AT NOMINAL PRESSURE. DEFLATION FAILED, AND THE DEVICE BECAME STUCK WITH THE GW. THERE WAS AN ATTEMPT TO REMOVE SYSTEM, BUT SABERX.014 RUPTURED. ECHO CONFIRMED THE RUPTURE. THE PROCEDURE WAS COMPLETED BY INSERTING A SHEATH ON THE OPPOSITE SIDE AND RETRIEVING THE RUPTURED BALLOON USING A GOOSENECK. THE PROCEDURE ENDED, BUT CONTRALATERAL PUNCTURE SITE DEVELOPED HEMATOMA. THE BALLOON MARKERS ARE NOT VISIBLE. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (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. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22432594 ↗
• MalfunctionApr 21, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, A 2MM X 300MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED TO PERFORM TREATMENT FROM THE PERONEAL ARTERY AND THE POSTERIOR TIBIAL ARTERY. HOWEVER, THERE WAS SEVERE CALCIFICATION, AND THE BALLOON RUPTURED. A NEW 2.5MM X 300MM SABERX .014 PTA BALLOON CATHETER WAS THEN INSERTED AND WAS ABLE TO CROSS THE LESION WITH SMALL ADVANCEMENTS OF THE BALLOON CATHETER. SEVERAL DILATIONS WERE PERFORMED WITH THE SECOND SABERX PTA BALLOON CATHETER, BUT THE DEFLATION BEGAN TO SLOW DOWN AND WHEN THE 2.5MM X 300MM SABERX PTA BALLOON CATHETER WAS PULLED BACK, THE BALLOON RUPTURED SLIGHTLY PROXIMAL TO THE MID PORTION OF THE 300MM¿S. THE BALLOON SEGMENT AND GUIDEWIRE LUMEN DISTAL TO THE RUPTURE SEPARATED FROM THE BALLOON CATHETER AND REMAINED IN THE PATIENT. AN UNKNOWN SNARING DEVICE ALONG WITH A NON-CORDIS CATHETER AND A NON-CORDIS GUIDE EXTENSION CATHETER WERE USED TO SUCCESSFULLY RETRIEVE THE SEPARATED WIRE LUMEN; HOWEVER, IT IS UNKNOWN IF A PORTION OF THE WIRE LUMEN REMAINS IN THE PATIENT. THE RUPTURED BALLOON SEGMENT REMAINED IN A CRUSHED STATE NEAR THE ENTRANCE OF THE ANTERIOR TIBIAL ARTERY, BLOCKING IT. THE PHYSICIAN ATTEMPTED TO PASS A NON-CORDIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874261 ↗