Sterling™ H74939032604010Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729122784), received between Dec 6, 2019 and Feb 4, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE- SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INFLATION, THE BALLOON RUPTURED WITHOUT REACHING THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259417 ↗
• InjuryJan 29, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON RUPTURED, AND THE TIP WAS DETACHED, REQUIRING INTERVENTION. THE OCCLUDED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT RENAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED AND INFLATED; HOWEVER, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 18 ATMOSPHERES FOR 20 SECONDS. THE CATHETER WAS REMOVED FROM THE PATIENT AND FOUND THE TIP WAS MISSING. A SECOND WIRE AND ANOTHER BALLOON WERE USED TO CAPTURE THE DETACHED PIECE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED. IT WAS FURTHER REPORTED VIA USER FACILITY#: (B)(4), THAT THE VASCULAR ACCESS WAS OBTAINED VIA LEFT RADIAL ARTERY. HOWEVER, THE LEFT BRACHIAL ARTERY WAS HIGHLY TORTUOUS. THE PHYSICIAN DECIDED TO PURSUE LEFT FEMORAL ARTERY ACCESS BY PLACING 6F SHEATH AND 6F STEERABLE SHEATH. THE LESION WAS WIRED WITH NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE AND DILATED WITH 2MM, 3MM AND 5MM NON-BSC BALLOON FOR 200 PULSES. AFTER THIS 6MM STERLING BALLOON RUPTURED, THE SHEATH AND BALLOON WERE REMOVED INTACT AND REINSERTED. THE LESION WAS WIRED AGAIN WITH 6MM ATHLETIS BALLOON, BUT IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266138 ↗
• MalfunctionOct 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION TO NORMAL BURST PRESSURE, THE BALLOON BURST. 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 20445835 ↗
• MalfunctionFeb 22, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE VERTEBRAL ARTERY. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE GUIDEWIRE BECOME STUCK WITH THE BALLOON. THE BALLOON AND GUIDEWIRE WERE SIMPLY WITHDRAWN FROM THE BODY, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BRAND. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758226 ↗
• MalfunctionJan 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR 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 18576419 ↗
• MalfunctionDec 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THERE WERE NO ANY FRAGMENTS LEFT INSIDE THE PATIENT AND THE DEVICE WAS REMOVED INTACT. SINCE THE BALLOON WAS DEFECTIVE, THE PHYSICIAN HAD TO USE ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LOWER LEG. THE DEVICE WAS SIMPLY PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16033434 ↗
• MalfunctionDec 21, 2022Material Twisted/Bent; Failure to Deflate; Material Twisted/Bent; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED WITH NO ISSUE AND WAS INFLATED WITH A CONTRAST RATIO OF 50/50. HOWEVER, IT WAS NOTICED THROUGH FLUOROSCOPY THAT THE BALLOON TWISTED. INFLATION DEVICE WAS RELEASED TO DEFLATE THE BALLOON, BUT THE BALLOON FAILED TO DEFLATE. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON USING THE INFLATION DEVICE WITH NO SUCCESS. THE BALLOON WAS INTENTIONALLY INFLATED UP AT 20 ATMOSPHERES TO BURST AND TO REMOVE FROM THE PATIENT. THE DEVICE WAS COMPLETELY REMOVED ALONG THE WIRE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022522 ↗
• MalfunctionNov 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERY. AFTER CROSSING THE LESION WITH A 0.014 300CM THRUWAY GUIDEWIRE, A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15747902 ↗
• MalfunctionOct 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED, TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15675094 ↗
• InjuryAug 18, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. A 6.0 MMX40 MMX135 CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON MATERIAL BURST IN HALF AND LEFT INSIDE THE PATIENT. THE PHYSICIAN DECIDED NOT TO RETRIEVE IT SINCE THE BALLOON FRAGMENT WAS OUTSIDE THE VESSEL AND WAS SUBCUTANEOUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION POST PROCEDURE WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15250380 ↗
• MalfunctionMay 23, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 6.0MM X 40MM X 135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING REMOVAL ATTEMPT, THE BALLOON WOULD NOT DEFLATE. THE DEVICE TOOK 20 MINUTES TO REMOVE BUT IT WAS REMOVED FULLY INFLATED FROM THE PATIENT'S BODY. A BUDDY WIRE WAS PLACED AND THE BALLOON AND SHEATH WAS REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ALTERNATE METHOD OR DEVICE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14474086 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE HEAVILY DISEASED TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. A 6.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS USED BUT IT ALSO RUPTURED AT THE SAME LOCATION. THE PROCEDURE WAS COMPLETED BY PLACING AN EPIC STENT AND POST-DILATING WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691118 ↗
• MalfunctionJun 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT POPLITEAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048301 ↗
• MalfunctionJun 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042585 ↗
• MalfunctionMar 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED (CTO) TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT EXTERNAL ILIAC ARTERY (EIA). AFTER PLACING THE 6FR GUIDING SHEATH, NON-BOSTON SCIENTIFIC GUIDEWIRES WERE TRIED TO CROSS, BUT FAILED. ANOTHER NON-BSC GUIDE WIRE CROSSED THE LESION, AND PRE-DILATION WAS PERFORMED USING 3MM NON-BSC AND 4MM COYOTE BALLOON CATHETERS, AND TWO ELUVIA DEVICES WERE PLACED. POST DILATION WAS THEN PERFORMED WITH 5X220 STERLING OTW BALLOON CATHETER, AND PROCEDURE IN SFA WAS COMPLETED. NEXT, WHEN IN-STENT DILATATION WAS PERFORMED USING 6.0MMX40MMX135CM (4F) STERLING IN 8X40 NON-BSC IN-STENT RESTENOSIS (ISR) IN EIA, THE BALLOON RUPTURED BEFORE REACHING 14 ATMOSPHERES ON THE SECOND INFLATION. AFTER IMAGING, STENOSIS IN ISR ALSO IMPROVED UNDER ANGIOGRAPHY, AND IT WAS ALSO CONFIRMED UPON IVUS. SINCE LUMEN ALSO EXTENDED, THE PROCEDURE WAS COMPLETED UP TO THIS POINT WITHOUT REPLACING THE DEVICE. THE TARGET TREATMENT WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575330 ↗
• InjuryMar 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 6MM X 40MM X 135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE IN AN ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST. THE BALLOON WAS THEN SNARED OUT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499301 ↗
• MalfunctionSep 14, 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 COMMON ILIAC ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 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 STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532585 ↗
• MalfunctionJul 20, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE BALLOON WAS ALREADY BROKEN IN THE PACKAGE INSIDE THE PLASTIC WRAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Patient Involvement

  MAUDE report 10295388 ↗
• MalfunctionMar 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE ANTERIOR TIBIAL ARTERY (ATA) AND SUPERFICIAL FEMORAL ARTERY (SFA). A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED IN THE ATA AND A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS PLACED IN SFA FOR DILATIONS. HOWEVER, DURING INFLATIONS, THE BALLOONS RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. BOTH DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787387 ↗
• MalfunctionFeb 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE 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 9739241 ↗
• MalfunctionJan 27, 2020Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. A 6 X 40 X 135 MM STERLING BALLOON WAS SELECTED FOR USE IN AN ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE THE PHYSICIAN NOTED THERE WAS DIFFICULTY INFLATING THE BALLOON. THE BALLOON WAS THEN UNABLE TO DEFLATE. IT WAS ABLE TO BE REMOVED FROM THE PATIENT. A NEW DEVICE WAS SELECTED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS AND THE PATIENT'S STATUS WAS OK POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633658 ↗
• MalfunctionDec 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED POPLITEAL ARTERY. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 2 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9425350 ↗