Sterling® SL H74939148251210Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729782261), received between May 14, 2020 and Nov 20, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24OCT2025. IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE PROPERLY. THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER LIMB. A 2.5MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS SELECTED FOR LOWER LIMB ANGIOPLASTY TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE PROPERLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE 102MM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607919 ↗
• MalfunctionFeb 24, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOSCLEROTIC OCCLUSION OF LOWER EXTREMITY. A 2.5MM X 120MM X 150CM STERLING SL WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447215 ↗
• MalfunctionSep 27, 2024Inflation Problem; Leak/Splash; Material Rupture; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Leak/Splash; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON BURST. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY WITH A 6F SHEATH AND A PLACEMENT OF NON-BOSTON SCIENTIFIC GUIDEWIRE. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LOWER EXTREMITY ARTERIAL OCCLUSION. THE 6F SHEATH REACHED THE LESION AND DETERMINED THE ANGIOGRAPHY. A V-18 HYDROPHILIC WIRE WAS ADVANCED WITH THE 2.5MM X 120MM X 150CM STERLING SL BALLOON CATHETER FOR DILATION. HOWEVER, THE BALLOON COULD NOT DILATE AND WAS QUICKLY REMOVED FROM THE PATIENT. THE NORMAL SALINE WAS USED TO DETECT THE ISSUE, AND FOUND THE BALLOON WAS BUBBLING, LEAKING GAS AND COULD NOT DILATE, BUT NO VISIBLE PINHOLE WAS NOTED. IT WAS DETERMINED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317863 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH VASCULAR SCLEROSIS AND STENOSIS OF LOWER EXTREMITY. A 2.5MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, AFTER UNPACKING, THE SHAFT WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587737 ↗
• MalfunctionFeb 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH ARTERIAL OCCLUSION OF THE LOWER KNEE VESSELS AND UNDERWENT ARTERY VASCULAR OPENING. THE TARGET LESION WAS LOCATED IN ANTERIOR TIBIAL ARTERY. A 2.5MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. INFLATIONS WERE PERFORMED THREE TIMES. HOWEVER, DURING THIRD INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16344096 ↗
• MalfunctionJul 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 120MM X 150CM STERLING SL AND 2.5MM X 80MM X 150CM COYOTE BALLOON CATHETER WERE ADVANCED FOR DILATION. BOTH BALLOON REACHED THE LESION SITE. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093659 ↗
• MalfunctionDec 14, 2020Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE DEVICE WAS INFLATED THRICE AT 10 ATMOSPHERES; HOWEVER, DURING INFLATION, CONTRAST COULD NOT BE SEEN. IT WAS INITIALLY SUSPECTED THAT THE CONTRAST WAS TOO DILUTED; HOWEVER, WHEN THE BALLOON WAS REMOVED AND INFLATED OUTSIDE, IT WAS FOUND THAT IT COULD NOT INFLATE. NO VISIBLE PINHOLE NOTED WITH THE DEVICE. AS PER PHYSICIAN, THE BALLOON SHAFT WAS FAULTY OR BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11004056 ↗
• MalfunctionMay 14, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON CATHETER WAS STUCK ON THE WIRE. THE TARGET LESION WAS LOCATED IN NON-SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY BELOW THE KNEE. PRE-DILATION WAS PERFORMED WITH A 2.0MM STERLING BALLOON. A 2.5MMX80MMX150CM STERLING SL BALLOON AND V18 GUIDEWIRE WERE SELECTED WERE SELECTED FOR USE. THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES. A 2.5MMX120MMX150CM STERLING SL BALLOON WAS SELECTED TO CONTINUE THE CASE. THE 2.5MMX120MMX150CM STERLING SL BALLOON CATHETER BECAME STUCK ON THE V18 GUIDEWIRE AND COULD NOT BE PUSHED FORWARD. BOTH BALLOON CATHETER AND GUIDE WIRE WERE THEN REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10058083 ↗