Sterling™ H74939032501510Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729845362), received between Sep 28, 2018 and Jun 25, 2025 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION FOR 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328821 ↗
• MalfunctionMar 17, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND DIFFICULTY REMOVAL OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 5.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 14 ATMOSPHERES FOR 90 SECONDS, THE BALLOON RUPTURED AND WAS DIFFICULT TO REMOVE EVEN AFTER FLUSHING THE HOOP. THE DEVICE WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME SIZE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620733 ↗
• MalfunctionMar 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE >80% STENOSED TARGET LESION WAS LOCATED IN A TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX80MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON LEAKED. IT WOULD NOT HOLD PRESSURE AFTER MULTIPLE INFLATIONS FOR 1-2 SECONDS, AND IT RUPTURED AT 2-4 ATMOSPHERES. ANOTHER 5.0X150X150-HYBRID STERLING BALLOON WAS USED, BUT IT ALSO RUPTURED AT 4 ATMOSPHERES FOR 5 SECONDS AFTER MULTIPLE ATTEMPTS OF INFLATION. BOTH BALLOONS WERE REMOVED FROM THE PATIENT WITH NO FRAGMENTS LEFT. NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620212 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 5.0MMX150MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE DEVICE BECAME DETACHED FROM THE SHAFT, RESULTING IN THE FORMATION OF A HALO-LIKE RING IN THE CENTER OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495604 ↗
• MalfunctionAug 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986401 ↗
• MalfunctionJun 10, 2024Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16MAY2024. IT WAS REPORTED THAT DIFFICULT TO TRACK OVER WIRE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0X150X150 STERLING WAS USED FOR DILATION. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS INSERTED IN THE TIP OF THE STERLING BALLOON, THE WIRE DID NOT GO INSIDE THE CATHETER BUT ON THE BALLOON PART, WHICH IS DILATED DUE TO THE INFLATOR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505711 ↗
• MalfunctionApr 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE MORE THAN 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO ADVANCE AN 035" X 135CM RUBICON OVER THE BIFURCATION, BUT THE CATHETER WOULD NOT ADVANCE DUE TO A MAJOR KINK IN IT. AFTER PLACING A 45CM SHEATH, ANOTHER 035" X 135CM RUBICON WAS OPENED AND SUCCESSFULLY USED TO CROSS OVER THE SUPPORTED BIFURCATION. THE PROCEDURE CONTINUED WITH ATHERECTOMY OF THE MID AND DISTAL SFA, AND POPLITEAL ARTERIES USING ROTABLATOR. A 5MM X 150MM X 150 CM STERILING BALLOON WAS INSERTED AND ADVANCED TO THE POPLITEAL - MID SFA LESION WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED 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 19011304 ↗
• MalfunctionNov 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE RIGHT LEG. A 5.0X150X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES FOR LESS THAN A MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18086172 ↗
• MalfunctionMay 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0X150X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431745 ↗
• MalfunctionMar 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY SUPERFICIAL FEMORAL ARTERY. A 5.0X150X150-HYBRID OTW STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED AND A PINHOLE WAS FOUND IN PROXIMAL PART OF THE DISTAL TIP. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13964202 ↗
• MalfunctionJun 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED POPLITEAL ARTERY. A 5.0X150X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 16 BARS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053349 ↗
• MalfunctionMar 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0X150X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. NO KNOWN PATIENT COMPLCIATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND NON-TORTUOUS POPLITEAL ARTERY. PREVIOUSLY, IT WAS REPORTED THAT THE BALLOON RUPTURED AT 12 ATMOSPHERES. NOW, IT IS REPORTED THAT IT RUPTURED AT 13 ATMOSPHERES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11433608 ↗
• MalfunctionDec 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10926677 ↗
• MalfunctionOct 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY. A 5.0X200X150, 5.0X150X150 STERLING AND A 6.0 X200, 135CM CHARGER BALLOON CATHETERS WERE USED FOR DILATIONS. HOWEVER, DURING INFLATION, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10696749 ↗
• MalfunctionOct 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0X150X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198997 ↗
• MalfunctionMar 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150 X 150 HYBRID FG STERLING OTW BALLOON CATHETER WAS ADVANCED FOR DILATION AND RUPTURED IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457418 ↗
• MalfunctionMar 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY OF LEFT LOWER EXTREMITY. A 5.0X150X150MM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH NON BSC DEVICE. NO PATIENT INJURY NOR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402311 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN (B)(6) 2018, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT'S QUALIFYING CONDITION AS RUTHERFORD CATEGORY 3. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) HAD 100% STENOSIS, REFERENCE VESSEL DIAMETER OF 5MM, A LENGTH OF 100MM AND WAS CLASSIFIED AS A TASC II A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING 4MM X 150MM BALLOON. POST PRE-DILATATION, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED WITH 5MM X 150MM STERLING BALLOON TO THE TARGET LESION. FOLLOWING, GRADE A DISSECTION WAS NOTED; HOWEVER, NO ACTION WAS TAKEN. POST DILATATION WAS ALSO PERFORMED. THE PATIENT WAS DISCHARGED AS AN OUTPATIENT. IN (B)(6) 2018, THE PATIENT DEVELOPED RESTENOSIS IN THE LEFT SFA. NO ACTION WAS TAKEN TO TREAT THE EVENT.

  Patient problems: Reocclusion; Restenosis; Vascular Dissection

  MAUDE report 8232669 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BILATERAL CLAUDICATION. IN (B)(6) 2018, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITION AS RUTHERFORD CATEGORY 3. INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. TARGET LESION WAS LOCATED IN THE RIGHT SFA HAD 99% STENOSIS, WITH A REFERENCE VESSEL DIAMETER OF 5 MM, A LENGTH OF 140 MM AND WAS CLASSIFIED AS A TASC II B LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING A 4 MM X 100 MM BALLOON. POST PRE-DILATATION, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED USING 5 MM X 150 MM STERLING BALLOON. WITH 0% RESIDUAL STENOSIS. ALSO, NON-TARGET LESION: LEFT EXTERNAL ILIAC ARTERY WAS TREATED WITH BARE METAL STENT. THE PATIENT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2018, 159 DAYS POST INDEX PROCEDURE, DURING PROTOCOL SCHEDULED 6 MONTHS FOLLOW UP, THE PATIENT WAS NOTED WITH BILATERAL CLAUDICATION. RUTHERFORD CLASS WAS NOTED TO BE 2 (MODERATE CLAUDICATION). IN (B)(6) 2018, SUBJECT PRESENTED FOR SCHEDULED ANGIOGRAPHY. ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED NOT RECOVERED/ NOT RESOLVED.

  Patient problems: Claudication

  MAUDE report 7920631 ↗