SABER 48004010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032069783), received between Nov 29, 2017 and Dec 2, 2024 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN INFLATING THE BALLOON OF A 4MM X 10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE PRESSURE COULD NOT BE RAISED TO 6 ATMOSPHERES (ATM) AND A RUPTURE WAS SUSPECTED. THE BALLOON WAS DEFLATED, BUT SOME BLOOD HAD WITHDRAWN, AND THE RUPTURE WAS CONFIRMED. A NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ARTERIOVENOUS (AV) SHUNT PTA PROCEDURE. THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED MODERATE CALCIFICATION, SEVERE TORTUOSITY, AND 70% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A NON-CORDIS 5F SHEATH WAS USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821105 ↗
• MalfunctionApr 21, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4 MM X 10 CM 90 CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER WAS USED BUT RUPTURED. THE COMPLAINT DEVICE WAS REPLACED WITH AN UNKNOWN SLALOM THRILL BALLOON CATHETER AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784693 ↗
• MalfunctionMar 9, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM X 10 CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT RUPTURED BEFORE REACHING ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE COMPLAINT PRODUCT WAS BEING USED IN A SHUNT PTA CASE. THE DEVICE WAS DISCARDED; THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518779 ↗
• MalfunctionSep 5, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF THE SABER 4MM 10CM COULD NOT BE RAISED TO NOMINAL PRESSURE (8ATM). THE BALLOON WAS REMOVED FROM THE PATIENT, THE BALLOON WAS EXPANDED OUTSIDE THE BODY, AND IT WAS NOTICED THAT THE BALLOON HAD LEAKAGE FROM A PINHOLE. THE TREATMENT WAS SUCCESSFUL AFTER IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER OF THE SAME SIZE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PROCEDURE WAS TO TREAT STENOTIC LESIONS IN THE LEFT SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, AND PULMONARY ARTERY. A 5F NON-CORDIS SHEATH WAS INSERTED THROUGH THE LEFT COMMON FEMORAL ARTERY WITH AN IPSILATERAL ANTEGRADE PUNCTURE. THE SHEATH CROSSED THE LESION ALONG WITH THE DEVICE. THEY BOTH PASSED THROUGH THE LESION AND WAS PREPARED TO USE FOR POP LESION DILATION. PRESSURE WAS APPLIED WITH THE INFLATION DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354273 ↗
• MalfunctionSep 17, 2021Leak/Splash; Leak/Splash

  AS REPORTED, A 4MM X 10CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AND INFLATED, HOWEVER, IT WAS CONFIRMED THAT THE CONTRAST MEDIA WAS LEAKING. THEREFORE, THE PHYSICIAN STOPPED USING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT PTA CASE. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488041 ↗
• MalfunctionAug 24, 2021Leak/Splash; Leak/Splash

  AS REPORTED, A 4MM X 10CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, HOWEVER, CONTRAST MEDIA LEAKAGE WAS CONFIRMED FROM ITS PROXIMAL SHAFT PART. THEREFORE, IT WAS REPLACED WITH A SAME SIZE NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A SHUNT PTA CASE. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362282 ↗
• InjuryNov 11, 2020Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN CONFIRMED THAT THE 4MM X 10CM X 90CM SABER RAPID EXCHANGE (RX) BALLOON CATHETER (BC) RUPTURED, THE CONTRAST MEDIUM WAS LEAKING FROM THE BLOOD VESSELS AND THERE WAS ALSO VASCULAR RUPTURING. AFTER THAT, HEMOSTASIS WAS ACHIEVED, AND IT WAS CONFIRMED THAT VESSEL WAS BLOCKED. THIS WAS A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THE DEVICE WAS USED TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY (POBA) THREE (3) TIMES AND THE PRESSURE WAS WITHIN ITS NOMINAL PRESSURE. THERE WAS RESIDUAL STENOSIS SO, THE PHYSICIAN INFLATED SABER TO RATED BALLOON PRESSURE TWICE. AT THE SECOND TIME (FIFTH TIME IN TOTAL), S/HE FELT THAT THE CONTRAST MEDIUM HAD COME OFF. ORIGINALLY IT WAS A DEFECT OF THE CHRONIC TOTAL OCCLUSIONS (CTO¿S) NON-GROWING SHUNT, BUT IT WAS THE PHYSICIAN¿S IMPRESSION THAT IT WAS OPENED AFTER PERFORMING THE THREE POBA AND WAS OCCLUDED AFTER THE VASCULAR RUPTURE BY BALLOON'S RUPTURE. SABER DEVICE RUPTURED IN A LESION WITH NO CALCIFICATION AND NO VASCULAR TORTUOSITY. IT WAS INFLATED WITHIN RATED BALLOON PRESSURE THAT WAS 18 ATMOSPHERIC PRESSURE (ATM). THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Perforation of Vessels

  MAUDE report 10824987 ↗
• MalfunctionJul 17, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 4MM X 10CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED FOR PRE-DILATION BUT IT RUPTURED AT 6 ATMOSPHERE (ATM). THEREFORE, IT WAS REPLACED WITH ANOTHER UNKNOWN 5MM 10CM BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED WITH DRUG-COATED BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS AT THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD CALCIFICATION. AN IPSILATERAL APPROACH WAS MADE. THE SABER PTA WAS USED IN CONJUNCTION WITH A 6F 11CM BRITE TIP SHEATH AND A NON-CORDIS GUIDEWIRE. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO CHECK THE LESION AND THE DEVICE. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). THE ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. THE VESSEL HAD MODERATE TORTUOSITY WITH 90% STENOSIS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. A NON-CORDIS INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289583 ↗
• MalfunctionNov 29, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE, IT WAS REPORTED THAT THE SABER PTA BALLOON CATHETER WAS DELIVERED TO THE LESION AND INFLATED, HOWEVER IT RUPTURED ABOUT NOMINAL PRESSURE. THE BALLOON WAS REPLACED WITH A NON CORDIS BALLOON AND THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE SHUNT PTA. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7067059 ↗

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