SABER 48008010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069745), received between Dec 29, 2023 and Aug 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  AS REPORTED, THE 8MM10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON LUER HUB LEAKED CONTRAST AGENT AS THE PRESSURE PUMP FILLED THE BALLOON TO DILATE THE LESION. THE BALLOON WAS INFLATED ONE TIME PRIOR TO THE LEAK. RESISTANCE/ FRICTION WAS NOTED WHILE INSERTING THE BALLOON CATHETER THROUGH THE ROTATING HEMOSTATIC VALVE AND WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS ALSO A DIFFICULTY NOTED WHILE CROSSING THE LEGION WITH THE BALLOON CATHETER. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NON-CORDIS BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE. 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 DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL WAS NOTED TO HAVE MODERATE TORTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030616 ↗
• MalfunctionDec 29, 2023Leak/Splash; Leak/Splash

  AS REPORTED, AFTER OPENING THE PACKAGING FOR AN 8MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE DISTAL BALLOON SEGMENT WAS FOUND COMPRESSED. A NON-CORDIS BALLOON CATHETER WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE IN WHICH IMAGING SHOWED A STENOSIS WITHIN THE ILIAC ARTERY WHICH REQUIRED BALLOON DILATATION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO OBSERVED DAMAGE TO THE DEVICE PACKAGING. THE DEVICE HAS NOW BEEN RETURNED. ADDENDUM: PRODUCT EVALUATION REVEALED A LEAKAGE ON THE BODY/SHAFT OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418665 ↗

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