SABER 48003008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032069332), received between Sep 7, 2021 and May 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Leak/Splash; Leak/Splash

  AS REPORTED, DURING PREPARATION OF A 3MM X 8CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE AIR WAS GOING BACK INTO THE SYRINGE AND NOT HOLDING THE AIR. ADDITIONALLY, THE BALLOON WOULD NOT HOLD INFLATION. ANOTHER 3MM X 8CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO OBSERVED DAMAGE ON THE LUER HUB OF THE INFLATION LUMEN AND THERE WAS NO DIFFICULTY CONNECTING THE SYRINGE TO THE LUER HUB PRIOR TO PREPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950180 ↗
• MalfunctionNov 6, 2024Deflation Problem; Deflation Problem

  AS REPORTED, THE BALLOON OF A 3MM X 8CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE COMPLETELY REVERTED TO ITS ORIGINAL STATE. IT TOOK 60 SECONDS TO DEFLATE THE BALLOON, WHICH WAS ABLE TO BE PARTIALLY DEFLATED AND WAS EVENTUALLY REMOVED AFTER PARTIAL DEFLATION. A NON-CORDIS BALLOON WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS ARTERIOSCLEROSIS OBLITERANS OF THE LOWER LIMB, WITH MILD CALCIFICATION, MILD TORTUOSITY, AND 70% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE BALLOON WAS INFLATED TO 18 ATM. NO LEAKAGE WAS OBSERVED DURING DEFLATION. NO RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE, WHICH WAS WITHDRAWN BY A NON-CORDIS LONG SHEATH. THE DEVICE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619681 ↗
• MalfunctionJun 7, 2024Partial Blockage; Partial Blockage

  AS REPORTED, THE 3MM 8CM SABER BALLOON WOULD NOT TRACK ON THE .014 VASSALLO WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THIS OCCURRED WHILE OUTSIDE THE PATIENT. THE .018 VASSALLO WIRE WOULD NOT ADVANCE PAST THE BALLOON. THE CASE WAS COMPLETED WITH THE USE OF A .018 SABER. THE VASSALLO WIRE WAS USED WITH THE NEW DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). 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. THE DEVICE WAS PREPPED FOLLOWING IFU WITHOUT DIFFICULTY. THE INNER STYLET WAS REMOVED. THE FEMORAL ARTERY WAS USED FOR ACCESS. THERE WERE NO PARTICLES WITHIN THE CATHETER THAT COULD HAVE BEEN INJECTED INTO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491097 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE INTRODUCER SLEEVE COVERING THE BALLOON OF A 3MM X 8CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT COME OFF DURING PREPARATION. A NEW 3MM X 8CM SABER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE INITIAL SABER PTA BALLOON CATHETER WAS NOT USED IN THE PATIENT AND THERE WERE NO REPORTED PATIENT INJURIES. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: THE DEVICE WAS RETURNED WITH THE BALLOON SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458564 ↗
• MalfunctionSep 7, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING DILATATION WITH A 3MM X 8CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER FOR AN INTERVENTIONAL PROCEDURE, THE BALLOON COULD NOT CONTINUE TO PRESSURIZE WHEN THE PRESSURE PUMP WAS USED TO HIT 8 ATMOSPHERES (ATM) AND IT RUPTURED. THEREFORE, THE LESION COULD NOT BE PRE-EXPANDED NORMALLY AND THE BALLOON WAS WITHDRAWN. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT UNDERWENT AN ANTEROGRADE PUNCTURE ON THE LEFT SUPERFICIAL ARTERY TO SEE THE LEFT ANTERIOR TIBIAL ARTERY OCCLUSION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432129 ↗

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