SABER 48005030XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032069578), received between Feb 5, 2019 and Mar 31, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE PATIENT WAS BROUGHT TO THE FACILITY WITH HISTORY OF PVD (PERIPHERAL VASCULAR DISEASE) FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) D/T. THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED SEVERE CALCIFICATION, NO TORTUOSITY, AND 99% STENOSIS. DURING THE PROCEDURE, ATHERECTOMY OF THE SFA WAS SUCCESSFULLY PREFORMED, FOLLOWED BY ATTEMPTED BALLOON ANGIOPLASTY WITH A 5MM X 30MM SABER PTA BALLOON CATHETER. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS 50% CONTRAST/50% SALINE. WHEN INFLATING THE BALLOON TO 6 ATMOSPHERES (ATM), IT WAS NOTICED THE BALLOON HAD RUPTURED AND IMMEDIATELY DEFLATED. UPON ATTEMPTING TO REMOVE THE SABER PTA BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON HAD BROKEN, AND THE DISTAL PORTION OF THE BALLOON WAS RETAINED IN THE VESSEL. MULTIPLE ATTEMPTS WERE MADE TO SNARE AND RETRIEVE THE SEPARATED BALLOON SEGMENT BUT WERE UNSUCCESSFUL. THE DECISION TO ABORT THE PROCEDURE WAS MADE AND NON-EMERGENTLY TRANSF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732397 ↗
• MalfunctionOct 17, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  AS REPORTED, AFTER THE INFLATION OF A 5MM X 30CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON ¿WAS NOT EASY TO HOLD BACK¿ AS IT WAS DIFFICULT TO REVERT THE BALLOON BACK TO ITS ORIGINAL STATE WHICH MADE IT DIFFICULT TO REMOVE FROM THE PATIENT. AN ATTEMPT TO RE-INFLATE THE BALLOON WAS MADE; HOWEVER, THE BALLOON COULD NOT BE COMPLETELY FILLED. THE BALLOON HAD TO BE INFLATED AND DEFLATED SEVERAL TIMES IN ORDER TO SUCCESSFULLY REMOVE THE DEVICE. THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT IN ONE PIECE AND A 5MM X 30CM NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE IN WHICH A RETROGRADE PUNCTURE WAS MADE. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED AN OCCLUSION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION HAD A 75% STENOSIS BUT THERE WERE NO SIGNS OF CALCIFICATION OR TORTUOSITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE BALLOON WAS PREPPED WITH A 1:1 CONTRAST TO SALINE RATIO AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE BALLOON WAS INFLATED TO 15 ATMOSPHERES (ATM) VIA AN UNKNOWN SYRINGE. THE DEVICE HAS NOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951041 ↗
• MalfunctionJul 20, 2020Crack; Crack

  AS REPORTED, CRACKS IN THE ¿INTERFACE¿ OF A 5MM X 30CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WERE FOUND IN PREPARATION FOR THE ¿SECOND BALLOON FILLING¿. THERE WAS NO REPORTED PATIENT INJURY. THE USER WAS TRAINED WITH THE DEVICE. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE TYPE OF DAMAGE NOTED ON THE DEVICE THAT IT WAS CRACKED. THE DEVICE DAMAGED WAS NOTED DURING USE. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGE. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE DEVICE WAS NOT USED IN PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296116 ↗
• InjuryFeb 5, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE SABER MM30CM 150 BALLOON WAS INFLATED IN A VERY LONG CALCIFIED, STENOSED ARTERY, HOWEVER DURING INFLATION, AT LOW ATMOSPHERES THE BALLOON EXPLODED, AND THE DOCTOR COULDN'T PULL OUT THE BALLOON OVER THE WIRE. THERE WERE NO REPORTED PATIENT INJURIES. AFTER THE DOCTOR USED A HIGH FORCE FOR TAKING THE BALLOON OUT, IT WAS MANAGED TO BE REMOVED SUCCESSFULLY, HOWEVER IT SEEMS AS IF PART OF THE BALLOON REMAINED INSIDE OF THE PATIENT. UNDER FLUOROSCOPY THE DOCTOR TOOK OUT THE GUIDE WIRE AND THE GUIDE CATHETER AND THE DOCTOR SAW THAT A PART OF THE BALLOON WITH THE MARKER BANDS WAS STUCK ON THE GUIDE WIRE. THE USER IS NOT SURE IF MORE PARTS ARE INSIDE OF THE PATIENT. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS 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 NORMALLY BY MAINTAINING NEGATIVE PRESSURE. A NON-CORDIS CONTRAST MEDIA WAS USED, WITH A CONTRAST TO SALINE RATIO 30: 70. A NON-CORDIS INDEFLATOR AND SYRINGE WAS USED. THE SAME INDEFLATOR WAS USED

  Patient problems: Foreign Body In Patient

  MAUDE report 8305443 ↗

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