Sterling™ H74939032502210Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729845409), received between Apr 27, 2020 and Sep 8, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that dissection occurred, requiring additional intervention.On (b)(6) 2026, the subject underwent treatment with the Eluvia Drug-Eluting Stent as part of the clinical trial. The target lesion #001 was located in the right mid superficial femoral artery, with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, a lesion length of 290 mm, and 95% stenosis, and was classified as a Trans-Atlantic Inter-Society Consensus (TASC II) C lesion. Prior to treatment with the study devices, pre-dilation was performed using a 5 mm X 220 mm Sterling OTW PTA balloon. Treatment of the target lesion was performed using 6 mm X 150 mm and 6 mm x 120 mm Eluvia Drug-Eluting Stents, followed by dilation with a 5 mm x 40 mm Ranger Drug-Coated Balloon. Following treatment, post-dilation was performed using a 6 mm x 150 mm Sterling OTW PTA balloon, and the final residual stenosis was noted to be 0%.On (b)(6) 2026, during treatment of the target lesion, a grade D dissection was noted in the right mid superficial femoral artery. The site confirmed that the 5 mm x 220 mm Sterling OTW PTA balloon was associated with the dissection. In response to the event,

  Patient problems: Vascular Dissection

  MAUDE report 50673764 ↗
• MalfunctionOct 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON WAS PERFORATED WHEN THE GUIDEWIRE WAS INSERTED. A STERLING BALLOON CATHETER WAS SELECTED FOR THE INDEX PROCEDURE. WHEN INSERTING AND ADVANCING THE GUIDEWIRE, HOWEVER, IT WAS NOTICED THAT THE DEVICE WAS PERFORATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STERLING BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, BUT THE EPISODE OF CARE WAS EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369415 ↗
• MalfunctionSep 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS VESSEL. A 5.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 20279586 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT MIDDLE SUPERFICIAL FEMORAL ARTERY. A 5.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 13 ATMOSPHERES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022280 ↗
• MalfunctionAug 6, 2024Inflation Problem; Material Rupture; Material Integrity Problem; Inflation Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0X220X150-HYBRID STERLING BALLOON WEAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN THE BALLOON WAS FIRST INFLATED AT 8 ATMOSPHERES, THE BALLOON COULD NOT BE FULLY OPENED AND SHOWED A WRINKLED SHAPE. CONSEQUENTLY, AFTER ADDING 2 ATMOSPHERES OF PRESSURE TO 10 ATMOSPHERES FOR 6-8 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19915820 ↗
• MalfunctionFeb 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PERONEAL ARTERY IN THE LOWER LEG. A 5.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR LOWER LEG EXTREMITY PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS FIRST INFLATED TO A PRESSURE OF 12 ATMOSPHERES AND AFTER 30 SECONDS THE BALLOON BURST. THE PHYSICIAN TOOK OUT THE DEVICE FROM THE PATIENT IN ONE PIECE WITHOUT ANY FRAGMENTS LEFT, AND THE PROCEDURE WAS COMPLETED WITH A RANGER DRUG-COATED BALLOON. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704386 ↗
• MalfunctionFeb 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0X220X150-HYBRID STERLING BALLOON WAS USED. DURING THE COURSE OF THE PROCEDURE, THE BALLOON RUPTURED. NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650984 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. THE MODERATELY STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0X220X150-HYBRID STERLING BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, BALLOON BURST OCCURRED AT THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526739 ↗
• MalfunctionJul 3, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER FROZE ON WIRE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 80% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. A 5.0 X 220 X 150 STERLING BALLOON CATHETER WAS INFLATED AT 6 ATMOSPHERES IN AN .014 NON-BOSTON SCIENTIFIC FILTER GUIDEWIRE. FOLLOWING DEFLATION OF THE BALLOON, THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON. HOWEVER, THE BALLOON WOULD NOT MOVE AND BECAME LOCKED ON THE WIRE. THE WIRE APPEARED BENT AT THE DISTAL END. BOTH DEVICES WERE TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252406 ↗
• MalfunctionJun 30, 2023Material Rupture; Material Twisted/Bent; Material Rupture; Material Twisted/Bent

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED AND NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). A FG STERLING OTW, 5.0X220X150-HYBRID BALLOON CATHETER WAS SELECTED FOR THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. PROBING THE SFA WAS SUCCESSFUL, AND THE PTA WAS STARTED WITH THE STERLING BALLOON. DURING THE FIRST INFLATION, HOWEVER, AT 10 ATMOSPHERES FOR ONE MINUTE, THERE APPEARED TO BE A CONSTRICTION IN THE MIDDLE OF THE BALLOON, AND THEN THE BALLOON RUPTURED. THE BALLOON WAS ABLE TO BE REMOVED AS NORMAL, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239911 ↗
• MalfunctionMar 28, 2023Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-MAR-2023. IT WAS REPORTED THAT BALLOON INFLATION ISSUES OCCURRED. THE PATIENT UNDERWENT LOWER LIMB ANGIOPLASTY. THE 60-80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY AND/OR POPLITEAL REGION. A 5.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION BUT WHEN INFLATING THE BALLOON, IT COULD NOT BE FULLY INFLATED TO NOMINAL ATMOSPHERES. PHYSICIAN TRIED TWICE AND SAME THING HAPPEN. THE BALLOON WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 5MMX 220MM 90CM STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631917 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0X220X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT NOMINAL PRESSURE FOR LESS THAN 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497781 ↗
• MalfunctionSep 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 40% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT BELOW 6 ATMOSPHERES, A PINHOLE WAS NOTICED ON THE BALLOON. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418558 ↗
• MalfunctionDec 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

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

  MAUDE report 10978377 ↗
• MalfunctionApr 27, 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 5.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 1-2 SECONDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003494 ↗