SABER 48002030XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032069233), received between Mar 14, 2022 and Sep 19, 2023 — classified as 4 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. 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.

• MalfunctionSep 19, 2023Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, WHEN PREPARING TO USE THE 2MM 30CM SABER BALLOON, IT WAS FOUND THAT THE GUIDEWIRE WOULD NOT COME OUT OF THE TAIL SEAT OF THE GUIDEWIRE LUMEN. INSTEAD CAME OUT OF THE HOLE WHERE THE BALLOON WAS INFLATED, AND THEREFORE COULD NOT BE USED. A NEW BALLOON OF THE SAME MODEL WAS USED TO ENSURE THAT THE PROCEDURE WAS PERFORMED PROPERLY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS. ONE PICTURE RELATED TO THE REPORTED FAILURE WAS EVALUATED. IMAGE EVALUATED: AS PART OF THE PICTURE, IR COULD BE OBSERVED THE HUB SECTION OF THE CATHETER. A RED ARROW IS DRAWN OVER THE HUB. NO OTHER ANOMALIES OF THE PRODUCT CAN BE NOTICED AT THE ATTACHED PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774717 ↗
• MalfunctionOct 11, 2022Leak/Splash; Leak/Splash

  AS REPORTED, AFTER THE INSERTION OF A 5MM X 10CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, AN ATTEMPT TO INFLATE THE BALLOON WAS MADE BUT THE INFLATION FAILED. IT WAS REPORTED THAT THE INFLATION DIFFICULTY MAY HAVE BEEN CAUSED BY A LEAKAGE OF PRESSURE FROM THE SHAFT OF THE DEVICE. AS A RESULT, THE DEVICE WAS REMOVED, AND A 5MM SABERX PTA BALLOON CATHETER WAS USED AND WAS SUCCESSFULLY INFLATED. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN UNKNOWN DRUG-COATED BALLOON (DCB) CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT RESTENOSIS OF A PREVIOUSLY PLACED UNKNOWN STENT WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN IPSILATERAL APPROACH WAS USED FOR THIS PROCEDURE. AN UNKNOWN .014 GUIDEWIRE WAS ALSO USED AND WAS ADVANCED ACROSS THE LESION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581863 ↗
• MalfunctionSep 30, 2022Partial Blockage; Burst Container or Vessel; Partial Blockage; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 2MM X 30CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST AND IT WAS REPORTED THAT THERE WAS AN UNDISCLOSED ISSUE WITH THE "Y-CONNECTOR". AS A RESULT, A NEW 2MM X 30CM 150CM SABER PTA BALLOON CATHETER WAS USED TO CONTINUE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT LOWER EXTREMITY ARTERIOSCLEROSIS. THE LESION HAD A 75% STENOSIS AND WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY AT THE TARGET LESION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE BALLOON WAS PREPPED WITH A 1:1 CONTRAST TO SALINE RATIO. 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 EXPERIENCED DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO TRACK TOWARD THE LESION AND CROSS THE LESION WITHOUT DIFFICULTY. THE DEVICE WAS NEVER PUT INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513877 ↗
• MalfunctionMar 14, 2022Partial Blockage; Partial Blockage

  AS REPORTED, A 2MM30CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER WOULD NOT INSERT OVER AN UNKNOWN WIRE. ANOTHER SABER PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. RESISTANCE WAS FELT AND THE BALLOON WAS NOT ABLE TO BE PLACED OVER THE WIRE AND WAS NEVER USED IN THE PATIENT. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO USE. THE INSERTION DIFFICULTY WAS NOT CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THE DEVICE IS BEING RETURNED FOR EVALUATION. ADDENDUM: ON PRODUCT EVALUATION, THE HUB AREA THAT PRESENTS THE OBSTRUCTION WAS INSPECTED WITH A VISION SYSTEM OBSERVING THAT THE GUIDEWIRE HITS WITH AN UNKNOWN FOREIGN MATERIAL. A CROSS SECTION CUT WAS MADE TO FIND OUT WHAT WAS OBSTRUCTING THE GUIDEWIRE LUMEN, AND AS A RESULT OF THE INVESTIGATION ONE PTFE SEGMENT WAS FOUND OBSTRUCTING THE LUMEN. PER ANALYTICAL ANALYSIS RESULTS, THE MATERIAL FOUND INSIDE THE COMPLAINT UNIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759567 ↗

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