SABERX .014 PTA Dilatation Catheter 47525300MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032089804), received between Mar 11, 2025 and Mar 16, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 2.5MM X 300MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE NOMINAL DILATION. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING BELOW KNEE (BK) TREATMENT. THERE WAS SEVERE CALCIFICATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607849 ↗
• MalfunctionDec 30, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 2.5MM X 300MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE NOMINAL EXPANSION. A NON-CORDIS DEVICE WAS USED AS A REPLACEMENT TO PERFORM PRE-DILATION. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A POPLITEAL ¿ BELOW KNEE (BK) VESSEL WITH CALCIFIED LESIONS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922330 ↗
• MalfunctionOct 22, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER PASSAGE OF AN UNKNOWN 0.014 WIRE, A 2.5 X 300 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS USED. DURING THE FIRST DILATION AT 8 ATM, THE BALLOON RUPTURED. A REPLACEMENT SABERX014 OF THE SAME SIZE WAS THEN USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A BELOW KNEE (BK) STENOSIS CASE USING AN IPSILATERAL APPROACH. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360926 ↗
• MalfunctionAug 11, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 2.5MM X 300MM SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WHEN PRESSURE WAS INCREASED TO 5 ATMOSPHERES (ATM). A NEW 2.5MM X 300MM SABERX PTA BALLOON CATHETER WAS OPENED AND WAS DILATED ABOVE 6 ATM WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A BELOW THE KNEE (BTK) LESION IN WHICH AN IPSILATERAL PUNCTURE WAS MADE. A NON-CORDIS GUIDEWIRE WAS INSERTED PRIOR TO USE OF THE INITIAL SABERX .014 PTA BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770782 ↗
• MalfunctionJul 9, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 2.5 X 300 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING A BELOW THE KNEE (BTK) PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON-CORDIS DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460454 ↗
• InjuryApr 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 21874475 ↗
• MalfunctionMar 11, 2025Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, AFTER AN UNKNOWN GUIDEWIRE CROSSED THE POSTERIOR TIBIAL ARTERY TO THE PLANTAR ARTERY LESION, THE 2.5 X 300 .014 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED. DURING DELIVERY IT, THE DOCTOR FELT RESISTANCE, BUT THE PUSHABILITY WAS GOOD AND IT COULD BE CROSSED THE LESION. THE BALLOON WAS INFLATED AND DEFLATED. AFTER THAT, THE DR. TRIED TO REMOVE IT. HOWEVER, THE DEFLATION WAS NOTICEABLY SLOW, SO WHEN THE DR. PULLED IT, AN UNUSUAL NOISE WAS HEARD. THE DR. TRIED TO REMOVE IT CAREFULLY, THE TWO DISTAL MARKERS WERE RETRACTING. IT SEEMED LIKE IT WOULD BE POSSIBLE TO RETRIEVE IT WITHOUT ANY PROBLEMS, BUT THEN RESISTANCE WAS FELT, AND THE SHAFT WAS CUT OFF EXTERNALLY OUTSIDE THE PATIENT'S BODY. A NON-CORDIS BALLOON CATHETER WAS FOLLOWED BY A NON-CORDIS CATHETER, TRAPPED DISTALLY, AND RETRIEVED OUTSIDE THE BODY WHILE CHECKING THE TWO MARKER PARTS OF THE BALLOON. AFTER REMOVAL, IT WAS CONFIRMED THAT THERE WAS NO BALLOON ATTACHED TO THE BALLOON SHAFT. SINCE ONLY THE BALLOON REMAINED INSIDE THE BODY, IT WAS REMOVED USING A SNARE. FURTHERMORE, THE BALLOON PART THAT REMAINED INSIDE THE BODY WAS EXAMINED, IT APPEARED THAT THE TIP WAS COVERED WITH THE BALLOON MATERIAL. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572484 ↗