SABER 48010004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069028), received between Jun 2, 2020 and Oct 14, 2024 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE 10MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BURST. THE BALLOON RUPTURED BELOW THE RBP. THE PROCEDURE WAS COMPLETED USING ANOTHER PTA DEVICE. ULTRASOUND-GUIDED ACCESS OF THE PROXIMAL RIGHT FOREARM FISTULA WAS DONE. AN UNKNOWN MICROPUNCTURE GUIDEWIRE OVER A TREASURE .018 WIRE WAS ADVANCED WITH A NON-CORDIS 2.6FR CXI CATHETER THROUGH THE LEVELS OF STENT INTO THE CENTRAL VENOUS SYSTEM. A 10 MM BY 4 CM SABER ANGIOPLASTY BALLOON WAS ADVANCED THROUGH THE JUNCTION OF THE BRACHIOCEPHALIC SUBCLAVIAN VEIN AND DILATED AREA. WASTING WAS DILATED WITH A BALLOON AT NOMINAL PRESSURE. WASTING WAS STILL PRESENT. THE BALLOON WAS TAKEN TO JUST BELOW BURST BUT THE BALLOON RUPTURED AT THIS POINT. THE BALLOON WAS WITHDRAWN BUT DURING THE WITHDRAWAL, THERE APPEARED TO BE DISRUPTION OF THE BALLOON. THE FRAGMENTS OF BALLOON WERE ABLE TO BE REMOVED AND THERE DID NOT APPEAR TO BE ANY RESIDUAL FOREIGN MATERIAL ON AN ANGIOGRAM OR REPEAT IMAGING WITH DUPLEX. FLOW WAS BRISK THROUGH THE FISTULA AND INTO THE CENTRAL VENOUS SYSTEM. AN X-RAY OF THE RIGHT AND LEFT SIDE OF LUNGS DID NOT DEMONSTRATE ANY EVIDENCE OF RADIOPAQUE FOREIGN MATERIAL. ACCESS SITE AFTER REMOVAL OF WIRE WAS CLOSED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441353 ↗
• MalfunctionJun 2, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 10MMX4CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BURST IN THE ARM OF THE PATIENT. THEREFORE, IT WAS REMOVED, AND ANOTHER PTA WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT INJURED. THE PRODUCT WAS STORED AS PER LABELING, OPENED IN STERILE FIELD AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE TARGET LESION WAS THE "STENTED" SEGMENT OF THE CEPHALIC ARCH WITH NO CALCIFICATION, NO VESSEL TORTUOSITY BUT WITH NINETY-FIVE PER-CENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER NOR DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50:50. A NON-CORDIS INDEFLATOR DEVICE WAS USED; AND THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE; NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER; NO DIFFICULTY ADVANCING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10108786 ↗

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