SABER 48008004XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032069721), received between Jun 9, 2023 and Jan 21, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Detachment of Device or Device Component

  AS REPORTED, THE PROXIMAL EDGE OF THE BALLOON ON AN 8MM X 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS SEPARATED OUT OF THE BOX. A SEPARATION WAS ALSO NOTED TO THE DISTAL PORTION OF THE PLASTIC BALLOON COVERING AND THERE WAS DIFFICULTY REMOVING THE BALLOON COVER. THE DEVICE DID NOT ENTER THE PATIENT AND WAS NOT USED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PEDAL ACCESS PROCEDURE IN WHICH A 4F 10CM RAIN TIBIAL PEDAL CATHETER SHEATH INTRODUCER (CSI) WAS USED. THERE WAS NO DAMAGE TO THE OUTER PACKAGING FOR THE SABER PTA BALLOON CATHETER OBSERVED PRIOR TO OPENING THE DEVICE. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING IT FROM THE PACKAGING. THE BALLOON COVER WAS NOT ROTATED OR TWISTED DURING REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136023 ↗
• MalfunctionOct 11, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM 4CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED BELOW THE RBP DURING INFLATION IN CALCIFIED VESSEL. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW SABER .014 BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING IT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR ANY STERILE PACKAGING COMPONENTS. KINKS OR DAMAGES WERE NOT NOTED PRIOR TO INSERTION. THE DEVICE WAS PREPPED ACCORDING TO THE IFU WHILE MAINTAINING NEGATIVE PRESSURE. THE INTENDED PROCEDURE IN THE POSTERIOR TIBIAL ARTERY, WHERE THE LESION WAS CHARACTERIZED BY MODERATE CALCIFICATION AND 85% STENOSIS, WITH NO VESSEL TORTUOSITY. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR WHILE CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND, AND IT DID NOT KINK DURING USE. THE CONTRAST TO SALINE RATIO WAS 50/50. THE DEVICE IS NOT BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433631 ↗
• MalfunctionJun 9, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER 8MM 4CM BALLOON BURST AT 8 ATM IN A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) LESION. THE CASE WAS COMPLETED AFTER THE PHYSICIAN PLACED A SMART STENT. 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, REMOVING THE PROTECTIVE BALLOON COVER, 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 PER THE IFU AND WAS DONE NORMALLY. THE BALLOON WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO RESISTANCE/FRICTION ENCOUNTERED WHILE INSERTING THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE ADVANCING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE VESSEL DID NOT HAVE ANY TORTUOSITY. THE LESION HAD A 60% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NEVER KINKED DURING USE. THE CONTRAST/SALINE RATIO WAS 1:1. THE INFLATION DEVICE USED WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097989 ↗

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