SABER 48005008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069585), received between Aug 30, 2021 and Aug 1, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 1, 2025Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON ON A 5MM X 8CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND LEAKING DURING USE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687277 ↗
• MalfunctionAug 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 5MM X 8CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER CAME OFF WHEN IT WAS LOADED OVER A .018¿ UNKNOWN WIRE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WAS NOT USED IN A PATIENT. THE INTENDED PROCEDURE WAS A SUPERFICIAL FEMORAL ARTERY (SFA) ANGIOPLASTY. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. A NEW BALLOON WAS OPENED, AND THE USER CONTINUED WITH THE PROCEDURE SUCCESSFULLY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12382569 ↗

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