SABER 48002504XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069257), received between Jan 12, 2021 and Apr 4, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• InjuryApr 4, 2025Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 4F 2.5 MM X 4 CM 150 CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WOULD NOT DEFLATE AFTER INITIAL INFLATION. RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE BECAUSE THE BALLOON WOULD NOT DEFLATE AND WAS STUCK ON THE GUIDEWIRE. THE DEVICE SEPARATED IN THE PATIENT AT THE PROXIMAL PORTION OF THE BALLOON JUNCTION WHERE IT MEETS THE SHAFT . IN AN ATTEMPT TO REMOVE THE BALLOON, THE USER PULLED VERY HARD AND THE STRAIN RELIEF AT THE JUNCTION WHERE IT MEETS THE SHAFT SEPARATED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECES. THEY WERE ABLE TO NAVIGATE A SECOND UNKNOWN .014¿ WIRE DOWN NEXT TO THE BALLOON TO MAINTAIN WIRE ACCESS. ATTEMPTS WERE MADE TO PULL THE DEVICE OUT SLOWLY, BUT IT WAS DETERMINED THE BALLOON WAS STUCK ON THE ORIGINAL UNKNOWN .018¿ GUIDEWIRE. THE UNKNOWN INTERVENTIONAL SHEATH WAS BROUGHT DOWN AS CLOSE AS POSSIBLE TO THE BALLOON AND THEN THE UNKNOWN .018¿ WIRE, BALLOON-STUCK ON THE WIRE, AND UNKNOWN SHEATH WERE ALL REMOVED TOGETHER AND UNKNOWN .014¿ WIRE ACCESS WAS MAINTAINED. THE DEVICE WAS OPENED IN A STERILE FIELD AND STORED PER PRODUCT LABELING. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774431 ↗
• 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. AS REPORTED, THE BALLOON OF 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 DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154515 ↗

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