SABER 48003010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069349), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Leak/Splash; Leak/Splash

  AS REPORTED, A NON-CORDIS CONTRAST MEDIA THAT WAS USED IN A PROCEDURE HAD LEAKED AT THE PROXIMAL-END OF THE BALLOON OF A 3MM 10CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) AND IT CANNOT BE FILLED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS ANTERIOR TIBIAL ARTERY. THE LESION WAS SEVERELY CALCIFIED. THERE HAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 90%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. RELEVANT MEDICAL HISTORY INCLUDED HAVING FOOT ULCER CAUSING THE PATIENT¿S INABILITY TO WALK AS NORMAL. THE INTENDED PROCEDURE WAS FOR BALLOON ANGIOPLASTY. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. A NON-CORDIS INDEFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY CROSSI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938314 ↗

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