SABERX .014 PTA Dilatation CatheterRecalls & reported problems across all models

We found 16 models of SABERX .014 PTA Dilatation Catheter by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2024 and Apr 8, 2026 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SABERX .014 PTA Dilatation Catheter problems

SABERX .014 PTA Dilatation Catheter models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SABERX .014 PTA Dilatation Catheter 47512015M

  Catheter, angioplasty, peripheral, transluminal
  8 reports
• SABERX .014 PTA Dilatation Catheter 47525300M

  Catheter, angioplasty, peripheral, transluminal
  7 reports
• SABERX .014 PTA Dilatation Catheter 47520300M

  Catheter, angioplasty, peripheral, transluminal
  3 reports
• SABERX .014 PTA Dilatation Catheter 47560200M

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• SABERX .014 PTA Dilatation Catheter 47530300L

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• SABERX .014 PTA Dilatation Catheter 47530300M

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• SABERX .014 PTA Dilatation Catheter 47540150M

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47560150M

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47550200M

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47530040M

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47525200M

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47520250L

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47525150M

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47535300M

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47520150M

  Catheter, angioplasty, peripheral, transluminal
  1 report
• SABERX .014 PTA Dilatation Catheter 47530200M

  Catheter, angioplasty, peripheral, transluminal
  1 report

Recent SABERX .014 PTA Dilatation Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Burst Container or Vessel

  AS REPORTED, A 3MM X 40MM SABERX .014 RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED WITHOUT ISSUE USING AN UNKNOWN REPLACEMENT PRODUCT. THERE WAS NO REPORTED INJURY TO THE PATIENT. 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. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY. THE DEVICE WAS USED FOR AN ENDOVASCULAR THROMBECTOMY (EVT). THERE WAS SEVERE VESSEL CALCIFICATION WITHOUT TORTUOSITY AND 100% STENOSIS. THERE WAS NO RESISTANCE OR FRICTION WILE INSERTING THE BALLOON THROUGH THE THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER OR ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE BALLOON CATHETER AND THE CATHETER WAS NEVER IN AN ACUTE BEND. THERE WAS NO BALLOON CATHETER KINK DURING USE. THE CONTRAST TO SALINE RATIO WAS 2:1. THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821749 ↗
• MalfunctionMar 18, 2026Burst Container or Vessel

  AS REPORTED, THE 3.0 X 300 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON PASSED THROUGH THE NON-CORDIS FIXED CATHETER (FC). HOWEVER, THE BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE/SIZE. AFTERWARDS, A 3.0 X 200 SABERX BALLOON WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632396 ↗
• MalfunctionMar 18, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 1.25MM X 15MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED ON ITS FIRST INFLATION TO 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED FROM THE PATIENT, AND A NON-CORDIS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A HIGHLY CALCIFIED ANTERIOR TIBIAL ARTERY (ATA) OCCLUSION VIA AN IPSILATERAL ANTEGRADE APPROACH. THE TARGET VESSEL WAS NOT TORTUOUS AND EXHIBITED 100% STENOSIS. THE SABERX .014 BALLOON CATHETER WAS BEING USED FOR PRE-DILATION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION, AND A 2:1 CONTRAST TO SALINE RATIO WAS USED. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND, WAS ABLE TO CROSS THE LESION, DID NOT KINK DURING THE PROCEDURE, AND WAS REMOVED EASILY FROM THE PATIENT. THE PRODUCT WAS REMOVED INTACT IN ONE PIECE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627774 ↗
• 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 ↗
• MalfunctionJan 16, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 1.25MM X 15MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT APPROXIMATELY 7 ATMOSPHERES (ATM) DURING DILATION OF THE DORSALIS PEDIS ARTERY. ANOTHER 1.25MM X 15MM SABERX .014 PTA BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON RUPTURED AGAIN AT APPROXIMATELY 13 ATMOSPHERES (ATM). A NON-CORDIS 1.5MM BALLOON CATHETER WAS THEN USED AS A REPLACEMENT AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT STENOSIS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), THE ANTERIOR TIBIAL ARTERY, AND THE DORSALIS PEDIS ARTERY. THE TARGET VESSEL WAS CHARACTERIZED BY MODERATE TO SEVERE CALCIFICATION, MODERATE TORTUOSITY, AND 100% STENOSIS. AN UNKNOWN 6F GUIDE SHEATH WAS INSERTED FROM THE LEFT GROIN, AND AN UNKNOWN .014 GUIDEWIRE WAS USED TO CROSS THE LESION. THE DEVICES WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING ANY STERILE PACKAGING COMPONENTS OR PROTECTIVE BALLOON COVERS. THE DEVICES MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. BOTH SABERX .014 PTA BALLOON CATHETERS WERE ABLE TO CROSS THE LESION PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093839 ↗
• MalfunctionJan 16, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 1.25MM X 15MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT APPROXIMATELY 7 ATMOSPHERES (ATM) DURING DILATION OF THE DORSALIS PEDIS ARTERY. ANOTHER 1.25MM X 15MM SABERX .014 PTA BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON RUPTURED AGAIN AT APPROXIMATELY 13 ATMOSPHERES (ATM). A NON-CORDIS 1.5MM BALLOON CATHETER WAS THEN USED AS A REPLACEMENT AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT STENOSIS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), THE ANTERIOR TIBIAL ARTERY, AND THE DORSALIS PEDIS ARTERY. THE TARGET VESSEL WAS CHARACTERIZED BY MODERATE TO SEVERE CALCIFICATION, MODERATE TORTUOSITY, AND 100% STENOSIS. AN UNKNOWN 6F GUIDE SHEATH WAS INSERTED FROM THE LEFT GROIN, AND AN UNKNOWN .014 GUIDEWIRE WAS USED TO CROSS THE LESION. THE DEVICES WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING ANY STERILE PACKAGING COMPONENTS OR PROTECTIVE BALLOON COVERS. THE DEVICES MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. BOTH SABERX .014 PTA BALLOON CATHETERS WERE ABLE TO CROSS THE LESION PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093789 ↗
• MalfunctionJan 12, 2026Burst Container or Vessel

  AS REPORTED, A 3.5MM X 300MM 150CM SABER X .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES IN A SAME-SIDE BELOW-THE-KNEE CASE. A NON-CORDIS PTA BALLOON WAS USED AS A REPLACEMENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, COULD NOT BE OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032704 ↗
• MalfunctionJan 9, 2026Material Rupture

  AS REPORTED, A 4 MM X 15 CM SABERX .014 150 CM PTA BALLOON CATHETER RUPTURED DURING INFLATION AFTER EXCEEDING NOMINAL PRESSURE. AFTER THE BALLOON RUPTURE, DILATION WAS PERFORMED WITH A NEW UNKNOWN 4 MM X 4 CM BALLOON, FOLLOWED BY AN UNKNOWN DRUG-COATED BALLOON, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE INVOLVED TREATMENT OF LEFT SUPERFICIAL FEMORAL ARTERY (SFA) TO BELOW-KNEE ARTERY (BKA) STENOSIS VIA RIGHT GROIN ACCESS, INSERTION OF AN UNKNOWN 6F GUIDING SHEATH, LESION CROSSING WITH AN UNKNOWN 0.014 GUIDEWIRE, AND PRE-DILATION USING AN UNKNOWN 1.25 MM X 1.5 CM BALLOON FOLLOWED BY AN UNKNOWN 3 MM X 4 CM BALLOON. IT WAS UNCLEAR WHETHER THE CAUSE OF THE BALLOON RUPTURE WAS LESION CALCIFICATION OR PRODUCT QUALITY. THE PRODUCT WAS STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING IT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTION. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE NORMALLY. THE INTENDED PROCEDURE WAS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) USING A CONTRALATERAL AP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026126 ↗
• MalfunctionJan 8, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABERX .014 PTA, 2.5 X 200, 150CM, RUPTURED BEFORE REACHING NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A BELOW-KNEE (BK) CASE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24008125 ↗
• 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 ↗
• MalfunctionDec 23, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING INFLATION OF A 1.25MM X 15MM SABERX.014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, CALCIFICATION WAS ENCOUNTERED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) LESION AND THE BALLOON RUPTURED. THE DEICE WAS REMOVED AND A 1.5MM X 40M NON-CORDIS BALLOON CATHETER WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO DIFFICULTY ENCOUNTERED IN REMOVING STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. NEGATIVE PRESSURE WAS MAINTAINED DURING PREPARATION. THE TARGET VESSEL EXHIBITED NO TORTUOSITY AND 100% STENOSIS. THE DEVICE WAS NOT PLACED IN AN ACUTE BEND DURING THE PROCEDURE AND WAS UNABLE TO CROSS THE LESION. THE DEVICE DID NOT KINK. IT WAS REMOVED EASILY AND INTACT IN ONE PIECE FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881345 ↗
• MalfunctionDec 11, 2025Burst Container or Vessel; Burst Container or Vessel

  DEVICE WAS DISCARDED AT SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785606 ↗
• MalfunctionNov 4, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 6MM X 200MM SABERX 014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 4 ATMOSPHERES (ATM). A NON-CORDIS DEVICE WAS USED, AND EXPANSION WAS POSSIBLE AT NOMINAL PRESSURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). 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 23464241 ↗
• 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 ↗
• MalfunctionOct 22, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 3MM X 200MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 8 ATMOSPHERES (ATM) DURING DILATION. A 3 X 180 NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A BELOW KNEE (BK) LESION WITH SEVERE CALCIFICATION, NO TORTUOSITY, AND 100% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE AND WAS ABLE TO CROSS THE LESION WITHOUT KINKING. THE DEVICE WAS REMOVED EASILY AND INTACT FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356853 ↗

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