SABER 48003520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032069394), received between Jul 31, 2020 and Dec 29, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3.5 * 200MM SABER BALLOON WAS EXPANDED IN THE INFERIOR GENICULAR ARTERY UNDER THE PRESSURE OF 16ATM DURING PTA OF THE LOWER EXTREMITIES. AFTER THAT, THE DILATION WAS NOT CONTINUED. THE BALLOON RUPTURED AND WAS TAKEN OUT IN TIME AND REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE USE OF A NON-CORDIS BALLOON CATHETER. THE PATIENT RETURNED TO THE WARD. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, 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 PER THE IFU AND WAS PREPPED NORMALLY. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE BALLOON RUPTURED DURING PRE-DILATION OF THE VESSEL. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THE DEVICE ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. THE DEVICE CROSSED THE LESION WITHOUT DIFFICULTY. THE LESION WAS NOTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070211 ↗
• MalfunctionJun 8, 2021Leak/Splash; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, THE BODY OF A 3.5MM X 20CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS LEAKED. IT WAS ALSO NOTED THAT THE DEVICE WAS USED BEYOND EXPIRATION DATE. THERE IS AN OVER-LABEL PROCESS IN (B)(6). ONLY 1 PRODUCT/UNIT WERE RECEIVED IN THIS CONDITION. THE AFFECTED LOT WAS SOLD TO THE ACCOUNT PRIOR TO THE EXPIRATION DATE. PER AFFILIATE, PRELIMINARY JUDGMENT IS THAT THE PREVIOUS DEALER WHO BOUGHT THIS PRODUCT HAD FABRICATED THE ENGLISH AND (B)(6) LABELING. BUSINESS WITH THIS PREVIOUS DEALER HAS BEEN TERMINATED. THIS PRODUCT WAS HANDED OVER TO THE NEW DEALER FROM THE OLD DEALER. THE NEW DEALER COULD NOT IDENTIFY THE FAKE LABELING. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A SUPERFICIAL FEMORAL OCCLUSION. THE LEAKAGE WAS NOTED DURING USE. THE LESION WAS NOT CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 80%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11954833 ↗
• MalfunctionJul 31, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 3.5 MM X 20CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BEGIN TO DEFLATE 2 MINUTES AFTER IT REACHED THE TIBIOPERONEAL (TP) TRUNK AND ANTERIOR TIBIAL (AT) ARTERY. THE BALLOON WAS ABLE TO DEFLATE SLOWLY THEREFORE, IT WAS REMOVED TO THE PATIENT¿S BODY AND ANOTHER SAME SIZE AND LOT SABER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS FROM THE BALLOON BURSTING. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREPPED PROPERLY AND WAS USED AFTER ATHERECTOMY. THE TARGET LESION WAS THE TIBIOPERONEAL TRUNK ARTERY (TP). THE VESSEL LEVEL OF CALCIFICATION IS MODERATE. THE VESSEL LEVEL OF ANGULATION AND TORTUOSITY IS MILD. THE DEVICE WAS PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON INFLATED NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS 10-ATMOSPHERES PRESSURE (ATM). THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10350154 ↗

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