SABER 48006010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032068717), received between Feb 5, 2019 and Mar 3, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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.

• MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING INSERTION INTO AN UNKNOWN SHEATH VIA AN UNKNOWN GUIDEWIRE, A 6MM X 10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS STUCK MIDDLE WAY OF THE WIRE, AND THE DISTAL TIP BROKE OFF. THIS DID NOT OCCUR DURING USE INSIDE OF THE PATIENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503197 ↗
• InjuryMar 24, 2022Deflation Problem; Deflation Problem

  AS REPORTED, THE BALLOON OF A SABER 6MM 10CM 90 WOULD NOT DEFLATE IN THE SFA; THEREFORE, THE DOCTOR HAD TO USE A LONG NEEDLE TO BURST THE PTA. ULTRASOUND WAS USED TO LOCATE THE PTA, AND THEN PLACED A NEEDLE THOUGH THE THIGH TO DEFLATE THE BALLOON. THE DOCTOR USED ANOTHER SABER PTA 6X10X90 BALLOON AND IT WORKED FINE AND CASE WAS COMPLETED. THE PATIENT WAS OK AND THERE WAS NO REPORTED INJURY. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON BY CUTTING THE SHAFT, IT WAS UNSUCCESSFUL. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING STYLET/STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE DEVICE WAS BEING USED TO POST DILATE A STENT. THE LESION WAS NOTED TO HAVE LITTLE CALCIFICATION WITH NO VESSEL TORTUOSITY. THE LESION HAD A 90% STENOSIS PRIOR TO STENTING. IT WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THE NON-CORDIS INFLATION DEVICE WAS FILLED WITH AN 80/20 CONTRAST/SALINE RATIO. THERE WAS NO RESISTANCE/FRICT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13896502 ↗
• MalfunctionDec 13, 2021Deflation Problem; Deflation Problem

  DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE, A 6MM X 10CM 90 SABER PTA BALLOON CATHETER WAS UNABLE TO BE DEFLATED AFTER INFLATION. THE PHYSICIAN REPEATED INFLATING AND DEFLATING MANY TIMES AND MANAGED TO INSERT IT INTO A SHEATH SOMEHOW. THE COMPLAINT DEVICE WAS REMOVED. A RADIAL ACCESS WAS USED. THERE WAS NO DIFFICULTY REMOVING THE COMPLAINT BALLOON FROM THE FORMING TUBE. THE DEVICE PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH THE OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE 99% OCCLUDED LESION (NOT A CHRONIC TOTAL OCCLUSION (CTO) DID NOT HAVE ANY CALCIFICATION. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON COULD NOT DEFLATE COMPLETELY. IT SEEMS THAT IT WAS PULLED INTO THE SHEATH WHEN IT WAS SLIGHTLY DEFLATED. THE PROCEDURE WAS COMPLETED BY INFLATING ¿SO IT ENDED SAFELY.¿ THERE WAS NO REPORTED PATIENT INJURY. 4 MP4 PROCEDURAL VIDEOS WERE RECEIVED AND ARE PENDING REVIEW. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983317 ↗
• MalfunctionFeb 5, 2019Deflation Problem; Deflation Problem

  AS REPORTED, THIS WAS A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) CASE, A SABER 6MM10CM 90 WAS INSERTED FOR THE OCCLUDED LESION AROUND THE ANASTOMOTIC PART; HOWEVER, IT WAS INFLATED AT FOURTEEN ATMOSPHERES, AND IT BECAME DEFLATED UNDER SIX ATMOSPHERES. THERE WERE NO REPORTED PATIENT INJURIES. THE PHYSICIAN THEN INFLATED THE SABER THREE OR FOUR TIMES AND IT DID NOT DEFLATE. THE PROCEDURE WAS COMPLETED WITH THE SAME SABER. IT WAS THEN REMOVED FROM THE PATIENT AND THERE WERE NO ANOMALIES NOTICED ON THE DEVICE. THE DEVICE WAS STORED ON A SHELF IN THE CATH LAB. THE DEVICE WAS STORED FOR A FEW DAYS. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WERE NO ANOMALIES NOTED WHILE PULLING NEGATIVE PRESSURE. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8305531 ↗

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