Sterling® SL H74939148301010Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729782292), received between Oct 23, 2018 and Feb 20, 2024 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT CATHETER LEAK OCCURRED. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A CONTRAST MEDIUM LEAKED INTO THE CATHETER TIP, AND BALLOON DID NOT EXPAND DURING DILATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT OF DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744262 ↗
• MalfunctionNov 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST AT 6 ATMOSPHERES BEFORE REACHING STANDARD PRESSURE. THE DEVICE WAS REMOVED WITH THE GUIDEWIRE AND CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18202893 ↗
• MalfunctionMay 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH ATHEROSCLEROSIS OF PERIPHERAL ARTERIES. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE PHYSICIAN TRIED TO INFLATE THE BALLOON, IT WOULD NOT HOLD ANY PRESSURE AT ALL, AND CONTRAST WAS OBSERVED OUTSIDE OF ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16905631 ↗
• MalfunctionFeb 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT ANGIOPLASTY IN LOWER LIMB. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0MMX150MMX150CM STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353838 ↗
• InjuryDec 19, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT AND BALLOON RUPTURE OCCURRED REQUIRING AN ADDITIONAL INTERVENTION. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE WHOLE TIP AT ABOUT HALF OF THE BALLOON WAS DETACHED AND THE BALLOON RUPTURED. THE ISSUE WAS NOTICED RIGHT AWAY AND ADDITIONAL INTERVENTION WAS PERFORMED TO RETRIEVE THE DETACHED SEGMENT FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009181 ↗
• MalfunctionOct 19, 2022Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-SEP-2022. IT WAS REPORTED THAT BALLOON LEAK WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MESENTERIC ARTERY. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THERE WAS NO PRESSURE WHEN PRIMING THE BALLOON. THE BALLOON COULD NOT BE INFLATED AND THERE MIGHT BE AIR LEAKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631707 ↗
• MalfunctionSep 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT HIGH PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480601 ↗
• MalfunctionJul 6, 2022Material Rupture; Device-Device Incompatibility; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE PHYSICIAN ALSO NOTED THAT THE HUB OF THE BALLOON HAD DIFFICULTY CONNECTING TO A THREE WAY STOPCOCK. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14938742 ↗
• MalfunctionDec 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION UNDER RATED BURST PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11103150 ↗
• MalfunctionDec 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY OF THE LEFT LEG. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A CHARGER BALLOON OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING INITIAL INFLATION AT 10 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11032989 ↗
• MalfunctionAug 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERO TIBEAL ARTERY. AFTER A V18 GUIDEWIRE PASSED THROUGH, A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443979 ↗
• MalfunctionMay 14, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON THE GUIDEWIRE OCCURRED. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER AND V-18 GUIDEWIRE WERE SELECTED FOR A PROCEDURE BELOW THE KNEE. THERE WAS DIFFICULTY ADVANCING THE STERLING SL BALLOON CATHETER OVER THE V-18 GUIDEWIRE. THE DEVICE BECAME STUCK ON THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10058053 ↗
• MalfunctionJul 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. AFTER A V-18 GUIDEWIRE CROSSED THE LESION, A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842237 ↗
• MalfunctionJul 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL BELOW THE KNEE. A 3.0MM X 100MM X 150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INITIAL INFLATION AT 4 ATMOSPHERES, THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8814494 ↗
• MalfunctionJul 16, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED TIBIAL ARTERY. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. THE BALLOON WAS INFLATED AT 6 ATMOSPHERES FOR 60 SECONDS WITH 50% CONTRAST RATIO. HOWEVER, THE BALLOON DEFLATED RATHER SLOWLY AFTER INFLATION. IT TOOK A FEW DEFLATION CYCLES BEFORE THE BALLOON WAS DEFLATED FLAT ENOUGH FOR REMOVAL. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793748 ↗
• MalfunctionMay 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE MODERATELY STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT 5 TO 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8630412 ↗
• InjuryMay 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT EXTERNAL ILIAC ARTERY. A 3.0 MM X 100 MM X 150 CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON SHEARED IN THE PATIENT'S ILIAC ARTERY. SUBSEQUENTLY, THE DETACHED PORTION OF THE BALLOON WAS TRAPPED WITH A BARE-METAL STENT AGAINST THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS UNINJURED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8616758 ↗
• MalfunctionApr 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514897 ↗
• MalfunctionDec 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING A LEFT POPLITEAL ARTERY DILATATION, A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED. HOWEVER, ON INITIAL INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182374 ↗
• MalfunctionOct 23, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. AFTER ATHERECTOMY WAS PERFORMED, A 3.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON WOULD NOT HOLD THE ATMOSPHERE PRESSURE. DURING REMOVAL AND AS THEY WITHDRAW BACK TO COLLAPSE THE BALLOON, BLOOD STARTED COMING. WHEN THE DEVICE WAS REMOVED, THE BALLOON WAS FILLED UP AND A PINHOLE AT THE DISTAL TIP WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MFR: RETURNED DEVICE CONSISTED OF A STERLING OTW BALLOON CATHETER. THE BALLOON WAS LOOSELY FOLDED WITH BLOOD IN THE BALLOON AND INNER LUMEN. THE TIP, BALLOON, MARKERBANDS, AND INNER/OUTER SHAFT WERE MICROSCOPICALLY AND VISUALLY INSPECTED. INSPECTION REVEALED TIP DAMAGE, AND TWO PINHOLES IN THE BALLOON MATERIAL THAT WERE LOCATED AT THE EDGES OF THE DISTAL MARKERBAND. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE DEVICE WAS FUNCTIONALLY TESTED BY ATTACHING AN INFLATION DEVICE (FILLED WITH WATER) TO THE HUB OF THE STERLING DEVICE. WHEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7996950 ↗