SABER 48010002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032069004), received between Mar 30, 2023 and Oct 16, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2023Crack; Crack

  AS REPORTED, THE TEAM NOTICED THAT THE TIP OF THE 10MM 2CM SABER BALLOON WAS DAMAGED UPON OPENING OF THE PACKAGE. A SECOND BALLOON FROM THE SAME LOT NUMBER WAS USED WITHOUT ANY ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGED NOTED TO THE PACKAGING OF THE DEVICE. THE BALLOON WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS STORED IN AN OMNICELL WHILE IN THE LAB. THERE WAS NO DIFFICULTY WHILE REMOVING FROM THE PACKAGING, WHILE REMOVING FROM THE HOOP, OR WHILE REMOVING THE PROTECTIVE BALLOON COVER. THE BALLOON WAS NOT ADVANCED INTO SHEATH OR PATIENT DUE TO NOTICEABLE DAMAGE. THE PROCEDURE WAS BALLOONING OF THE PULMONARY ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939120 ↗
• MalfunctionMay 26, 2023Crack; Crack

  AS REPORTED, THE BALLOON OF A SABER (10MM 2CM) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER WAS CRACKED AT THE TIP WHEN IT WAS OPENED. THE DEVICE WAS UNABLE TO BE USED INSIDE OF THE PATIENT, AND AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE STORED AND OPENED AS PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY DURING THE REMOVAL. THERE WAS NO DAMAGE TO THE STERILE PACKAGING. THE DAMAGE TO THE DEVICE WAS NOTICED AFTER REMOVING THE DEVICE FROM IT PACKAGING. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014358 ↗
• MalfunctionMar 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, ON TWO SEPARATE 10MM2CM SABER BALLOONS WERE BEING PREPPED FOR A PROCEDURE. DURING PREP OF THE DEVICES, THE TIPS OF THE BALLOONS CAME OFF. THE PATIENT WAS NOT HARMED BECAUSE THE BALLOON NEVER ENTERED THE BODY. THE TEAM WAS UNAWARE THAT THE BALLOON WAS EXPIRED. THE BALLOONS APPEARED TO BE IN GOOD WORKING CONDITION WHEN THEY WERE REMOVED FROM THE PACKAGE, BUT ONE BALLOON WAS NOTED TO BE DEFECTIVE WITH THE ONLY INTERACTION BEING FLUSHING THE PORT. I DO NOT KNOW HOW THE TIP CAME OFF. I NOTICED THE SEPARATED TIP ON MY GLOVE AS I WAS LOADING THE BALLOON ON THE WIRE. I VISUALLY INSPECTED THE SECOND TIP ONCE IT WAS REMOVED FROM THE BODY (NOT INFLATED) AND NOTICED THE DAMAGE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659020 ↗
• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, ON TWO SEPARATE 10MM2CM SABER BALLOONS WERE BEING PREPPED FOR A PROCEDURE. DURING PREP OF THE DEVICES, THE TIPS OF THE BALLOONS CAME OFF. THE PATIENT WAS NOT HARMED BECAUSE THE BALLOON NEVER ENTERED THE BODY. THE TEAM WAS UNAWARE THAT THE BALLOON WAS EXPIRED. THE BALLOONS APPEARED TO BE IN GOOD WORKING CONDITION WHEN THEY WERE REMOVED FROM THE PACKAGE, BUT ONE BALLOON WAS NOTED TO BE DEFECTIVE WITH THE ONLY INTERACTION BEING FLUSHING THE PORT. I DO NOT KNOW HOW THE TIP CAME OFF. I NOTICED THE SEPARATED TIP ON MY GLOVE AS I WAS LOADING THE BALLOON ON THE WIRE. I VISUALLY INSPECTED THE SECOND TIP ONCE IT WAS REMOVED FROM THE BODY (NOT INFLATED) AND NOTICED THE DAMAGE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16647912 ↗

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