SABER 48002004XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069899), received between May 11, 2017 and Jan 12, 2021 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THREE , 2MM X 4CM 150, 5MM X 15CM 150, AND 2.5MM X 4CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETERS BURST DURING INFLATION PRIOR TO NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154074 ↗
• MalfunctionMay 11, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A 2X40MM SABER BALLOON CATHETER RUPTURED AT THREE ATMOSPHERES (3 ATM). THEREFORE, THE BALLOON WAS REPLACED WITH A NEW SABER BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS 100 % (CHRONIC TOTAL OCCLUSION [CTO]). THE DEVICE PREP NORMALLY. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. A GUIDEWIRE CROSSED THE LESION AND A SABER WAS DELIVERED FOR AN INFLATION HOWEVER IT RUPTURED AT 3 ATM. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6560205 ↗

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