Sterling® SL H74939148301590Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729782490), received between Jun 11, 2020 and Nov 10, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 18, 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.

• MalfunctionNov 10, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. A STERLING SL 3.00MM X 150MM, 90CM BALLOON CATHETER WAS SELECTED FOR USE TO TREAT PERIPHERAL ARTERIAL DISEASE OF THE SUPERFICIAL FEMORAL ARTERY, WHERE IT WAS NOTED THAT THE STENOSED TARGET LESION WAS VERY CALCIFIED. ANOTHER MANUFACTURER 0.035-INCH GUIDEWIRE COULD NOT PASS, BUT THE 0.018-INCH WAS ABLE TO PASS THROUGH THE STENOSIS. THE CATHETER WAS ADVANCED TO THE LESION, HOWEVER DURING DILATION THE CALCIFICATION WAS SO STRONG THAT THE BALLOON WAS DAMAGED AND WAS KNOCKED DOWN. THE PHYSICIAN REMOVED THE BALLOON, BUT THE SECOND PART OF THE STERLING REMAINED INSIDE AND WAS ABLE TO BE FULLY REMOVED ALONG WITH THE GUIDEWIRE. ANOTHER STERLING SL 3.00MM X 150MM, 90CM BALLOON CATHETER WAS USED TO DILATE THE LESION A BIT, AND A SMALLER SIZED STERLING BALLOON CATHETER WAS CHOSEN, HOWEVER, WAS NOT COMPATIBLE WITH THE GUIDEWIRE. POST- DILATION THE LARGER 0.035-INCH GUIDEWIRE WAS ABLE TO PASS, AND AN ATHLETIS WAS CHOSEN TO COMPLETE THE PROCEDURE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15772753 ↗
• MalfunctionJul 23, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE MORE THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE LOWER LIMB ARTERY BELOW THE KNEE. AFTER A 200CM, 8CM V-18 CONTROL WIRE WAS USED TO CROSS THE LESION, A 3.0MM X 150MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. UPON REMOVAL OF THE BALLOON, IT WAS NOTED THAT THE BALLOON NOT ABLE TO SLIDE OVER THE GUIDEWIRE AND THE WIRE WAS STUCK INSIDE THE BALLOON SHAFT. BOTH DEVICES WERE PULLED-OUT OF THE SHEATH AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218601 ↗
• MalfunctionJul 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND CALCIFIED POPLITEAL ARTERY. A 3.0MM X 150MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112231 ↗
• MalfunctionJun 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL BELOW THE KNEE. TWO 3.0MM X 150MM X 90CM STERLING SL BALLOON CATHETERS WERE ADVANCED FOR USE CONSECUTIVELY. HOWEVER, BOTH BALLOONS RUPTURED ON INITIAL INFLATION AT 12-14 ATMOSPHERES. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143323 ↗
• MalfunctionJun 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL BELOW THE KNEE. TWO 3.0 MM X 150 MM X 90 CM STERLING SL BALLOON CATHETERS WERE ADVANCED FOR USE CONSECUTIVELY. HOWEVER, BOTH BALLOONS RUPTURED ON INITIAL INFLATION AT 12-14 ATMOSPHERES. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143321 ↗