Sterling™ H74939032804010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729720676), received between Sep 29, 2020 and Jul 7, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (3 reports).

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

• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON DETACHED FROM THE GUIDEWIRE. AN 8.0MM X 40MM X 35CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON DETACHED FROM THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22418683 ↗
• MalfunctionJul 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 8.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704740 ↗
• InjuryJan 12, 2024Material Rupture; Failure to Deflate; Material Rupture; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND CALCIFIED VESSEL. AN 8.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED TO TREAT A PERIPHERAL VASCULAR DISEASE. THE DEVICE WAS PREPARED AND INSERTED AS PER INSTRUCTIONS FOR USE AND THE BALLOON WAS INFLATED WITH ENCORE 26 INFLATION DEVICE OVER THE LESION. WHEN NEGATIVE PRESSURE WAS APPLIED TO DEFLATE THE DEVICE, THE BALLOON WOULD NOT FULLY DEFLATE. THE BALLOON WAS ATTEMPTED TO DEFLATE MULTIPLE TIMES WITH NO SUCCESS. THE PHYSICIAN THEN TRIED TO DILUTE 50% CONTRAST AND 50% SALINE SOLUTION WITH A HIGHER CONCENTRATION OF SALINE, HOWEVER, THE DEFLATION ISSUE WAS NOT RESOLVED. THE PHYSICIAN THEN PULLED THE PARTIALLY DEFLATED BALLOON TO THE DISTAL END OF THE SHEATH INSIDE THE PATIENT'S BODY AND TRIED TO PULL THE BALLOON AGAINST THE SHEATH TO TRY TO DEFLATE THE BALLOON FURTHER, BUT STILL DID NOT WORK. AS THERE WAS NO OTHER WAY, THE PHYSICIAN THEN DECIDED TO BURST THE BALLOON. THE BALLOON BURST FRAGMENTS WAS DISLODGED FROM THE BALLOON CATHETER AND WERE LEFT INSIDE THE PATIENT'S ARTERY. THE PHYSICIAN PERFORMED SURGICAL PROCEDURE TO CUT DOWN THE BLOOD VESSEL TO REMOVE THE BALLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506960 ↗
• InjuryMar 24, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE AND UNDERWENT ANGIOGRAM. A 8.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS ATTEMPTED TO BE DEFLATED FOR 20 MINS DURING REMOVAL BUT WOULD NOT DEFLATE. THE BALLOON WAS POKED WITH WIRES AND WAS EVENTUALLY POPPED BY PUNCTURING IT WITH A NEEDLE THROUGH THE COMMON FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611119 ↗
• InjuryJun 9, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A FISTULA IN THE ARM. A 8.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE FOR 30 MINUTES. MANY ATTEMPTS TO DEFLATE THE BALLOON WITH ADDITIONAL INFLATION DEVICES AND SYRINGES DID NOT WORK. THE PHYSICIAN PUNCTURED THE BALLOON WITH A DIRECT STICK FROM THE OUTSIDE THE BODY THROUGH THE ARM GRAFT, INTO THE BALLOON. THE BALLOON FULLY DEFLATED AND WAS REMOVED. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644213 ↗
• InjuryNov 12, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED VIA MEDWATCH #M5096959 THAT A BALLOON DEFLATION FAILURE OCCURRED, REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AN 8.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING DEFLATION, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON USING INSUFFLATION DEVICE. THE PHYSICIAN WAS ABLE TO GET ENOUGH AIR OUT TO PASS BALLOON THROUGH RETRACTION. ADDITIONAL INTERVENTION WAS REQUIRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10829260 ↗
• InjurySep 29, 2020Failure to Deflate

  BALLOON WAS INFLATED IN ILIAC ARTERY, WHEN PHYSICIAN TRIED TO DEFLATE BALLOON, BALLOON WOULD NOT DEFLATE. SEVERAL ATTEMPTS WERE MADE TO DEFLATE BALLOON USING INSUFFLATION DEVICE, PHYSICIAN WAS ABLE TO GET ENOUGH AIR OUT TO PASS BALLOON THROUGH FOR RETRACTION. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10605998 ↗