SABER 48002020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20705032069219), received between May 8, 2018 and Jul 24, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Leak/Splash; Leak/Splash

  AS REPORTED, AFTER DELIVERING A 2MM X 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER OVER A NON-CORDIS GUIDEWIRE, THE PRESSURE OF THE PRESSURE PUMP DOES NOT GO UP. A LEAKAGE WAS OBSERVED DURING THE ATTEMPTED INFLATION, AND THE BALLOON DID NOT INFLATE AT ALL. A NEW 2MM X 20CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PTA PROCEDURE TO TREAT A 50% STENOSED ANTERIOR TIBIAL ARTERY LESION WITH NO CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO USED WAS 1:1. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586775 ↗
• MalfunctionJul 1, 2025Leak/Splash; Leak/Splash

  AS REPORTED, THE 2MM 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON BROKE DURING BALLOON DILATATION ANGIOPLASTY OF LOWER EXTREMITY ARTERIES. THERE WAS A HOLE ON THE BALLOON; THEREFORE, IT CANNOT BE INFLATED. THE PROCEDURE WAS COMPLETED BY CHANGING TO A NEW BALLOON. 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. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS FOR THE PERONEAL ARTERY. THE LESION WAS STENOTIC. THE LESION WAS MILDLY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 70%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE CONTRAST TO SALINE RATIO WAS 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373930 ↗
• MalfunctionApr 28, 2025Leak/Splash; Leak/Splash

  AS REPORTED, THE OPERATOR USED A 2 MM × 20 CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON ON THE ANTERIOR TIBIAL ARTERY. AFTER POSITIONING THE BALLOON AND ATTEMPTING INFLATION WITH A PRESSURE PUMP, IT LEAKED AND WOULD NOT INFLATE. THE BALLOON WAS REMOVED FROM THE BODY, AND A SECOND ATTEMPT TO INFLATE IT OUTSIDE ALSO FAILED. A 3 MM SABER .018 BALLOON WAS THEN USED TO DILATE THE ANTERIOR TIBIAL ARTERY, AND THE PROCEDURE FINISHED SMOOTHLY WITH NO PATIENT DISCOMFORT. THIS OCCURRED DURING A BELOW-THE-KNEE ARTERIAL BALLOON DILATION. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920369 ↗
• MalfunctionMar 31, 2024Leak/Splash; Leak/Splash

  AS REPORTED, THE 2MM 20CM SABER BALLOON COULD NOT BE FILLED INSIDE THE BODY AND WAS TESTED AFTER BEING WITHDRAWN AND WAS FOUND TO BE LEAKING. 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 19009316 ↗
• MalfunctionJan 12, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 2MM 20CM SABER BALLOON WAS NOTED TO HAVE RUPTURED BELOW RBP. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NON-CORDIS HIGH PRESSURE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PROCEDURE WAS A BALLOON DILATATION OF THE LOWER EXTREMITY. THE LESION WAS AT THE P1 SEGMENT OF THE POPLITEAL ARTERY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS REMOVED FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING, REMOVING THE PRODUCT FROM THE HOOP, AND THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE LESION WAS NOTED TO HAVE SEVERE CALCIFICATION WITH MODERATE TORTUOSITY. THE LESION WAS NOTED TO HAVE A 90% STENOSIS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503713 ↗
• MalfunctionJul 10, 2023Partial Blockage; Detachment of Device or Device Component; Partial Blockage; Detachment of Device or Device Component

  AS REPORTED, A 2MM X 2CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO TRACK TOWARDS A CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) LESION AS IT ENTERED THE PATIENT ALONG A NON-CORDIS .018 GUIDEWIRE. THERE WAS ALSO DIFFICULTY REMOVING THE SABER PTA BALLOON CATHETER WHICH REQUIRED THE BALLOON CATHETER AND NON-CORDIS GUIDEWIRE TO BE REMOVED TOGETHER. AS A RESULT, A NEW 2MM X 2CM 150CM SABER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. A CONTRALATERAL APPROACH WAS USED FOR THIS PROCEDURE, AND IT WAS REPORTED THAT AN INFLATION OF 8 ATMOSPHERES (ATM) WAS MADE WITH THE BALLOON WITHIN THE POPLITEAL ARTERY PRIOR TO THE RESISTANCE EXPERIENCED. THE BALLOON WAS FULLY DEFLATED PRIOR TO REMOVING THE DEVICE AND THE DEVICE WAS ABLE TO BE REMOVED IN ONE PIECE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: THE 2MM X 2CM 150CM SABER PTA BALLOON CATHETER WAS RETURNED IN TWO SEPARATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286620 ↗
• MalfunctionJan 12, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SHAFT OF THE SABER 2MM20CM 150 BALLOON WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS RETURNED FOR EVALUATION. A LEAK ON THE BODY/SHAFT OF THE UNIT WAS PRESENT, REVEALING A DAMAGE ON THE BODY SHAFT SURFACE. SEM ANALYSIS SHOWED A RUPTURE ON THE BODY SHAFT SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237852 ↗
• MalfunctionJul 11, 2019Partial Blockage; Partial Blockage

  AS REPORTED, THE GUIDE WIRE COULD NOT PASS THROUGH THE SABER (2MM20CM 150) BALLOON, AND THE BALLOON COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. A NON-CORDIS GUIDEWIRE WAS USED. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE BOX, POUCH, HOOP OR BALLOON SLEEVE. THERE WAS NO DIFFICULTY REMOVING THE BALLOON SLEEVE. THERE WERE NO KINKS NOTED ON THE DEVICE PRIOR TO USE. THE ACCESS SITE HAD CALCIFICATION BUT NO SCARRING. THE DEVICE WAS NOT INSERTED INTO THE PATIENT. THERE WERE NO KINKS NOTED ON THE DEVICE DURING OR AFTER USE. FORCE WAS NEVER REQUIRED WHEN USING THE DEVICE. THE DEVICE WAS NOT OBSTRUCTED WITH PARTICLES THAT COULD HAVE BEEN INJECTED INTO THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE SAME GUIDEWIRE WAS SUCCESSFULLY USED WITH ANOTHER DEVICE. PER FAL ANALYSIS, AN OBSTRUCTION WAS OBSERVED INSIDE THE GUIDEWIRE LUMEN; THEREFORE, A CROSS-SECTION ANALYSIS WAS PERFORMED ON THE OBSTRUCTED AREA. PER CROSS-SECTION ANALYSIS, THE OBSTRUCTED AREA OBSERVED ON THE GUIDEWIRE LUMEN WAS SECTIONED AND A FOREIGN MATERIAL WAS FOUND BLOCKING THE LUMEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781451 ↗
• MalfunctionMay 10, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING INFLATION OF THE SABER BALLOON CATHETER, IT WAS REPORTED THAT THE BALLOON RUPTURED AT BELOW THE RATE BURST PRESSURE. THERE WAS NO PATIENT INJURY. THE DEVICE COULD NO LONGER BE USED AND IT WAS REPLACED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504777 ↗
• MalfunctionMay 10, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING INFLATION OF THE SABER BALLOON CATHETER, IT WAS REPORTED THAT THE BALLOON RUPTURED AT BELOW THE RATE BURST PRESSURE. THERE WAS NO PATIENT INJURY. THE DEVICE COULD NO LONGER BE USED AND IT WAS REPLACED WITH ANOTHER DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE BY THE LOCAL QRA TO GET FURTHER INFORMATION UNSUCCESSFULLY (I.E. THE EVENT DATE OF EACH COMPLAINT). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504712 ↗
• MalfunctionMay 8, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING INFLATION OF THE SABER BALLOON CATHETER, IT WAS REPORTED THAT THE BALLOON RUPTURED AT BELOW THE RATE BURST PRESSURE. THERE WAS NO PATIENT INJURY. THE DEVICE COULD NO LONGER BE USED AND IT WAS REPLACED WITH ANOTHER DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE BY THE LOCAL QRA TO GET FURTHER INFORMATION UNSUCCESSFULLY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7494534 ↗

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