SABER 48004010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032069479), received between Mar 6, 2019 and Sep 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Partial Blockage; Partial Blockage

  AS REPORTED, AFTER CROSSING THE LESION WITH A NON-CORDIS GUIDEWIRE, THERE WAS RESISTANCE IN THE GUIDEWIRE LUMEN OF 4MM X 10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND THE DEVICE COULD NOT BE PUSHED TO THE LESION SITE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT AND NO SEPARATION OCCURRED. A NEW 4MM X 15MM SABER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT OR SIGNS OF INFECTIOUS DISEASE. THIS WAS DURING A PROCEDURE TO DILATE A 60% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA) LESION. WHICH HAD MODERATE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING COMPONENTS. THE GUIDEWIRE RESISTANCE WAS NOT CAUSED BY A POSSIBLE INJECTABLE MATERIAL. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED AN OBSTRUCTION WITHIN THE SABER PTA BALLOON CATHETER CAUSED BY A DETACHED PIECE OF THE INNER GUIDEWIRE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130122 ↗
• MalfunctionAug 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER CROSSING THE LESION WITH A NON-CORDIS GUIDEWIRE, THERE WAS RESISTANCE IN THE GUIDEWIRE LUMEN OF 4MM X 10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND THE DEVICE COULD NOT BE PUSHED TO THE LESION SITE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT; HOWEVER, THE DEVICE DID NOT REMAIN IN ONE PIECE DURING ITS REMOVAL. THE SEPARATED SEGMENT WAS ABLE TO BE WITHDRAWN. THE DAMAGE WAS NOT SEEN ON THE BALLOON MATERIAL. A NEW 4MM X 15MM SABER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT OR SIGNS OF INFECTIOUS DISEASE. THIS WAS DURING A PROCEDURE TO DILATE A 60% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA) LESION. WHICH HAD MODERATE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING COMPONENTS. THE GUIDEWIRE RESISTANCE WAS NOT CAUSED BY A POSSIBLE INJECTABLE MATERIAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918891 ↗
• MalfunctionJun 28, 2024Material Frayed; Difficult to Remove; Material Split, Cut or Torn; Material Frayed; Difficult to Remove; Material Split, Cut or Torn

  AS REPORTED, THE BOTTOM BALLOON PORTION ON A 4MM X 10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DETACHED AT ITS CONNECTION POINT AND FLIPPED INSIDE OUT DURING REMOVAL FROM THE BODY. THE BALLOON APPEARED TO HAVE GOTTEN CAUGHT UP ON A 6F NON-CORDIS SHEATH DURING REMOVAL; HOWEVER, THE BALLOON WAS REMOVED IN ITS ENTIRETY. THERE WERE NO REPORTED INJURIES TO THE PATIENT. AN ANTEGRADE APPROACH WAS USED FOR THIS PROCEDURE. THE BALLOON WAS INFLATED AND DEFLATED THREE TIMES WITHOUT ISSUE PRIOR TO THE DETACHMENT OF THE DISTAL BALLOON SECTION. THE PROXIMAL BALLOON SECTION REMAINED ATTACHED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633282 ↗
• MalfunctionDec 1, 2023Partial Blockage; Partial Blockage

  AS REPORTED, AN UNKNOWN GUIDEWIRE COULD NOT PASS THROUGH THE GUIDEWIRE LUMEN MARKED "THRU" OF A SABER 4MMX10CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THE PROCEDURE WAS COMPLETED AFTER EXCHANGING THE DEVICE WITH ANOTHER UNKNOWN PRODUCT OF THE SAME SIZE. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE WAS NOTED WHEN LOADING THE BALLOON ONTO THE GUIDEWIRE TO INSERT INTO THE PATIENT. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, NOR WAS THERE ANY DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. ADEQUATE FLUSH WAS USED/MAINTAINED THROUGHOUT PROCEDURE. THE ACCESS VESSEL WAS THE COMMON FEMORAL ARTERY (CFA). THE CFA HAD NO CALCIFICATION BUT WAS A LITTLE TORTUOUS. STENOSIS WAS UNDER 10%. THERE WAS NO BIFURCATION OF THE VESSEL. THE DEVICE DID NOT KINK AT ANY TIME WHILE ATTEMPTING TO INSERT ONTO GUIDEWIRE. OTHER PRODUCTS, SUCH AS AN UNKNOWN SABER BALLOON, WERE SUCCESSFULLY USED WITH THE DEVICE PRIOR AFTER THE ENCOUNTERED RESISTANCE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247240 ↗
• MalfunctionMar 6, 2023Deflation Problem; Deflation Problem

  AS REPORTED, AFTER DILATION OF THE 4MM 10CM SABER BALLOON, IT FAILED TO RETRACT. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487354 ↗
• MalfunctionDec 20, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MM 10CM 150 SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) USED FOR POST DILATION OF AN UNKNOWN STENT IN THE POPLITEAL ARTERY, RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. A BRACHIAL APPROACH WAS INITIALLY MADE. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504269 ↗
• MalfunctionMar 6, 2019Structural Problem; Structural Problem

  AS REPORTED, THE MARKER BANDS ON A SABER BALLOON CATHETER (4MM10CM 150) WERE OUT OF POSITION. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8397353 ↗

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