SABER 48002002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032069769), received between Nov 15, 2018 and Jan 13, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 2MM X 2CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT ITS NOMINAL PRESSURE DURING THE SECOND INFLATION. THEREFORE, IT WAS REMOVED EASILY INTACT IN ONE PIECE FROM THE PATIENT AS THE GUIDEWIRE REMAINED. IT WAS REPLACED WITH A NEW CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INTENDED FOR A BELOW THE KNEE PROCEDURE WITH AN IPSILATERAL APPROACH. THE EXACT TARGET LESION WAS THE ANTERIOR TIBIAL ARTERY (ATA). THE 90% OCCLUDED TARGET LESION HAD MODERATE CALCIFICATION AND LITTLE VESSEL TORTUOSITY. THERE WAS CALCIFICATION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) UP TO THE ANTERIOR TIBIAL ARTERY (ATA). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND 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 PREP NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582710 ↗
• MalfunctionJan 7, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 2MM X 2CM 90¿ SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. IT WAS USED AS PRE-PLAIN OLD BALLOON ANGIOPLASTY (POBA) AND WAS DELIVERED TO THE LESION WITHOUT ANY PROBLEMS. IT WAS REPLACED WITH ANOTHER UNKNOWN BALLOON CATHETER AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. AN IPSILATERAL APPROACH WAS MADE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560754 ↗
• MalfunctionNov 19, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN UNKNOWN GUIDE WIRE CROSSED THE LESION AND A 2 MM X 2 CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INSERTED; HOWEVER, IT RUPTURED AT 6 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE LEFT ANTERIOR TIBIAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO). THERE WAS MODERATE CALCIFIED LESION, NO VESSEL TORTUOSITY BUT WITH 100% STENOSIS. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU AND THE DEVICE WAS PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS 50% CONTRAST TO SALINE RATIO. A NON-CORDIS INFLATION DEVICE WAS USED WHICH WAS THE SAME INDEFLATOR USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9341585 ↗
• MalfunctionSep 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 90¿ 2 MM X 2 CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED WITHIN ITS NOMINAL PRESSURE AFTER HITTING THE VESSEL CALCIFICATION. THE SABER WAS THEREFORE REPLACED WITH A NEW NON-CORDIS BALLOON OF THE SAME SIZE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A PTA CASE. THE SABER WAS FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU). THE LESION WAS THE LEFT POPLITEAL ARTERY. THE LESION WAS 2 CM, HAD ECCENTRIC CALCIFICATION AND A RATE OF STENOSIS OF 99%. AN IPSILATERAL APPROACH WAS MADE WITH A NON-CORDIS SHEATH AND A NON-CORDIS GUIDEWIRE. THE SABER CROSSED THE LESION AFTER THE GUIDE WIRE. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125358 ↗
• MalfunctionSep 16, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER PTA (2MM2CM 90) BALLOON CATHETER WAS INSERTED FOR INFLATION. HOWEVER, IT RUPTURED AT 6-ATMOSPHERES PRESSURE (ATM). THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, THE SABER PTA BALLOON WAS REPLACED WITH A NEW DIFFERENT SIZE SABER PTA BALLOON CATHETER AND IT COULD BE INFLATED AND THE PROCEDURE WAS COMPLETED. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON INFLATED NORMALLY. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO PART OF THE DEVICE THAT FRACTURED NOR SEPARATED INSIDE THE PATIENT BODY. NO PART OF THE DEVICE MIGRATED INSIDE THE PATIENT BODY. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE IS NO PROCEDURAL FILM/CD AVAILABLE FOR REVIEW. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS DISCARDED DUE TO PATIENT¿S INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9071364 ↗
• MalfunctionNov 15, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT EIGHT ATMOSPHERE AFTER A COMPETITOR'S GUIDEWIRE AND GUIDE CATHETER WAS INSERTED IN THE PATIENT. THERE WAS NO PATIENT INJURY. THE SABER PTA BALLOON CATHETER WAS REPLACED WITH A NEW SABER X (2MM*20MM) AND THE PATIENT WAS CONFIRMED TO HAVE GOOD BLOOD-FLOW AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE RIGHT BELOW THE KNEE WHICH WAS SLIGHTLY CALCIFIED, NOT TORTUOUS WITH EIGHTY PERCENT STENOSIS. THERE WERE NO DIFFICULTY INFLATING THE BALLOON DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE IS NOT AVA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075681 ↗

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