SABER 48004025XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032069172), received between Dec 21, 2016 and Feb 3, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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.

• MalfunctionFeb 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER 4MM 25CM COULD NOT PASS THE LESION BECAUSE OF THE LONG AND CALCIFIED SFA LESION. THE BALLOON INFLATION WAS ATTEMPTED, BUT IT DID FAIL TO INFLATE. A BALLOON BURST WAS FOUND DURING DEVICE ANALYSIS. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PROPERLY STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING, REMOVING FROM THE HOOP. THE DEVICE WAS INSPECTED AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU. THE VESSEL WAS NOTED TO HAVE SEVERE TORTUOSITY. THERE WERE NO KINKS OR OTHER DAMAGES NOTED AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, SOME INFORMATION WAS NOT OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16298054 ↗
• MalfunctionNov 29, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 25CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO INFLATE AND EXPAND THE LESION DURING AN INFLATION TO 8 ATMOSPHERES (ATM). MULTIPLE ATTEMPTS TO INFLATE THE DEVICE WERE MADE BUT WERE UNSUCCESSFUL. AS A RESULT, THE DEVICE WAS REMOVED, AND A NEW SABER PTA BALLOON CATHETER WAS USED. THERE WERE NO REPORTED PATIENT INJURIES OR ADVERSE EVENTS DURING THIS PROCEDURE. THIS WAS DURING A PROCEDURE TO TREAT A 75% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH HAD MILD CALCIFICATION BUT NO VESSEL TORTUOSITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THERE WAS NO RESISTANCE OR FRICTION DURING INSERTION OF THE DEVICE, AND THE DEVICE WAS ABLE TO TACK TOWARDS THE LESION WITHOUT ISSUE. THE DEVICE DID NOT KINK DURING ITS USE. THE DEVICE WAS ABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875630 ↗
• MalfunctionAug 31, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM 25CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER APPEARED ¿PUNCTATE¿, RUPTURED, AND SPRAYED WITH WATER WHEN FILLING. THE MAXIMUM INFLATION PRESSURE WAS 10 ATMOSPHERES (ATMS). THERE WAS NO PATIENT INJURY. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE ACCESS SITE LOCATION WAS THE FEMORAL ARTERY. THE TARGET SITE HAD LITTLE CALCIFICATION, NO TORTUOSITY, AND 55% STENOSIS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. GE CONTRAST MEDIA WAS USED. THE CONTRAST TO SALINE RATIO WAS 1:1. A MERIT INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE DID NOT HAVE TO PASS THROUGH A PREVIOUSLY PLACED STENT. THE BALLOON WAS INFLATED ONCE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474426 ↗
• InjuryDec 21, 2016Burst Container or Vessel; Material Frayed; Difficult to Remove; Burst Container or Vessel; Material Frayed; Difficult to Remove

  DURING THE USE OF A SABER BALLOON CATHETER (4MM25CM 150) TO THE SUPERFICIAL FEMORAL ARTERY (SFA), IT WAS REPORTED THE BALLOON BURST DURING INITIAL INFLATION AT 5 ATMOSPHERES (ATM). WHILE RETRIEVING THA BALLOON FROM THE PATIENT, THE DISTAL PART OF THE BALLOON GOT STUCK IN THE SHEATH AND THE BALLOON TORN APART INSIDE THE PATIENT. A PIECE OF ABOUT 15CM LENGTH WAS RETRIEVED WITH A SNARE. THERE WAS NO PART OF THE BALLOON LEFT IN THE PATIENT. THE PROCEDURE WAS ENDED WITHOUT ANY FURTHER TREATMENT. AS THE PATIENT NEEDS SURGERY IN THE CFA, THEY MIGHT THEN TREAT IN THE SAME INTERVENTION AGAIN THE SFA. THE CURRENT STATUS OF THE PATIENT WAS NOTED TO BEING ¿GOOD¿. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES.  THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6194768 ↗

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