SABER 48006008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069608), received between Jul 22, 2024 and May 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionMay 19, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THERE WAS A SMALL HOLE AT THE BASE OF THE BALLOON ON A 6 MM X 8 CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PERIPHERAL INTERVENTIONAL PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044403 ↗
• MalfunctionJul 22, 2024Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  AS REPORTED, THE 6MM 8CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS ADVANCED TO THE DISTAL SFA LESION FOR POST DILATATION AFTER STENT PLACEMENT TO ENSURE GOOD ARTERIAL WALL APPOSITION OF THE STENT. THE BALLOON WAS PREPPED AND ADVANCED TO TARGET LESION WITHOUT PROBLEMS. WHILE ATTEMPTING TO INFLATE THE BALLOON TO 8 ATM, ONLY THE DISTAL END OF THE BALLOON INFLATED WHILE THE MID AND PROXIMAL ENDS OF THE BALLOON WOULD NOT INFLATE. UPON TRYING TO DEFLATE THE BALLOON THE DISTAL END OF THE BALLOON WOULD NOT DEFLATE. UPON TRYING TO PULL THE BALLOON INTO THE SHEATH FOR REMOVAL AND THE BALLOON BROKE IN HALF. THE PROCEDURE WAS ABORTED WITH ALL COMPONENTS OF THE BALLOON BEING SUCCESSFULLY REMOVED FROM THE PATIENT. THE 6MM 8CM SABER WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). 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 NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN THE DISTAL SUPERFICIAL FEMORAL ARTERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802620 ↗

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