Sterling™ H74939032302210Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729860174), received between Oct 4, 2018 and Jan 5, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 16, 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.

• InjuryJan 5, 2026Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 3.0X220X150 (4F) FG STERLING OTW BALLOON WAS SELECTED FOR A PROCEDURE TO TREAT A PATIENT. DURING THE PROCEDURE, THE STERLING OTW BALLOON RUPTURED INSIDE OF THE PATIENT. THE STERLING OTW BALLOON WAS RECOVERED USING VARIOUS ACTION AND EQUIPMENT INCLUDING A SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959494 ↗
• MalfunctionJan 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 3.0X220X150 (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE BALLOON PORTION OF THE CATHETER WAS DETACHED PRIOR TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON CATHETER. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT, AND PROCEDURAL FACTORS WERE NOT FOUND TO CONTRIBUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941732 ↗
• InjuryDec 9, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON RUPTURED AND BALLOON DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 3.0X220X150 (4F) STERLING BALLOON CATHETER WAS SELECTED FOR BILATERAL LOWER EXTREMITY ARTERIOGRAM. DURING INFLATION, THE BALLOON WAS RUPTURED. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL PORTION OF THE BALLOON HAD DETACHED FROM THE SHAFT. ATTEMPTS TO RETRIEVE THE BROKEN SEGMENT WERE UNSUCCESSFUL. AN INNOVA 6 X 40 STENT WAS IMPLANTED BESIDE THE BROKEN PORTION OF THE BALLOON TO ENCAPSULATE THE DETACHED SEGMENT BETWEEN THE STENT AND THE ARTERIAL WALL, FOLLOWED BY POST-DILATION TO ENSURE PROPER WALL APPOSITION. THE PHYSICIAN BELIEVED THE DEVICE FAILURE CONTRIBUTED TO THE COMPLICATION, AS THE PATIENT REQUIRED A STENT TO ADDRESS THE BROKEN BALLOON AND PROPERLY MANAGE THE ARTERIAL WALL. THE PATIENT HAD FULLY RECOVERED AT THE TIME OF REPORTING. IT WAS FURTHER REPORTED THAT THE RATED BURST RATE WAS 14 ATMOSPHERES HOWEVER, THE PHYSICIAN REACHED ABOUT 10 ATMOSPHERES BEFORE THE BALLOON BURST. THE BALLOON WAS INFLATED ONCE. THE INFLATION MEDIUM USED WAS A CONTRAST DYE AND SALINE COMBINATION (APPROXIMATELY 40/60).

  Patient problems: Foreign Body In Patient

  MAUDE report 23758045 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 3.0X220X150 (4F) STERLING BALLOON WAS USED FOR A LEG ANGIOPLASTY. PRIOR TO INSERTION, THE DEVICE BROKE. THE DEVICE WAS NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978608 ↗
• MalfunctionSep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON BROKE OFF AND SEPARATED FROM THE SHAFT UPON REMOVAL. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0 X 220 X 150 (4F) STERLING? BALLOON WAS ADVANCED FOR DILATION. HOWEVER, UPON REMOVAL FROM THE BODY, IT WAS NOTED THAT THE BALLOON BROKE OFF AND SEPARATED FROM THE SHAFT OF THE CATHETER. THE DEVICE WAS SIMPLY PULLED OUT WITH THE SHEATH, AND THE SEPARATED BALLOON REMAINED ON GUIDEWIRE. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY, AND NOTHING ADDITIONAL WAS DONE AFTER SUCCESSFUL INFLATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947593 ↗
• MalfunctionMay 26, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED TIBIAL ARTERY. A 3.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084850 ↗
• MalfunctionJan 10, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO DEFLATE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING REMOVAL, THE BALLOON DID NOT FULLY DEFLATE AND COULD NOT BE REWRAPPED AS WELL AS IT SHOULD BE. 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 18487466 ↗
• MalfunctionDec 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE MORE THAN 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. FOLLOWING ATHERECTOMY WITH ROTABLATOR, A 3.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 5 ATMOSPHERES, THE BALLOON WOULD NOT HOLD PRESSURE AND HAD BLOOD RETURN. UPON REMOVAL, IT WAS NOTED THAT THE BALLOON HAD BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260591 ↗
• MalfunctionOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 0.018 V18 GUIDE WIRE WAS USED IN CANNULATION OF THE RIGHT BRACHIAL ARTERY WITH STENOSIS OF THE DISTAL BRACHIAL MULTIPLE STENOSIS AFTER RADIAL ARTERY. A 3.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON WITH SUCCESSFUL ANGIOPLASTY DONE WITHOUT RUPTURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597590 ↗
• MalfunctionSep 30, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON BURST AND SEPARATED INTO TWO PARTS. A 3.0 X 220 X 150 STERLING BALLOON CATHETER WAS SELECTED FOR USE IN A BALLOON ANGIOPLASTY PROCEDURE. WHILE INFLATING THE STERLING BALLOON, THERE WAS AN IMPLOSION AND IT BECAME SECTIONED IN TWO PARTS WITH RISK OF MIGRATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513706 ↗
• MalfunctionApr 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND CALCIFIED PERONEAL ARTERY. A 3.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 3 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220317 ↗
• MalfunctionMay 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON SEPARATION OCCURRED. A 3.0X220X150 (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE DEVICE WAS STUCK IN PACKAGING AND THE WHEN PULLED OUT, THE BALLOON SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850448 ↗
• InjuryFeb 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PORTION OF THE BALLOON BECAME SEPARATED AND REMAINED IN THE PATIENT. A 4F 3MM X 220MM X 150CM STERLING WAS SELECTED FOR USE IN A BALLOON ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE POST DILATION, THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. IT WAS THEN DISCOVERED THAT A PORTION OF THE BALLOON HAD SEPARATED AND REMAINED IN THE PATIENT. ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE FRAGMENT, BUT THEY WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH A COVERED STENT. THE PATIENT WAS FINE AND IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11318763 ↗
• MalfunctionFeb 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 3.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11311080 ↗
• MalfunctionDec 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 4 ATMOSPHERES, 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; No Consequences Or Impact To Patient

  MAUDE report 11019384 ↗
• MalfunctionMar 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON HAD A HOLE. THE 90-95% STENOSED, TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0X220X150 STERLING CATHETER WAS ADVANCE FOR DILATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON WAS OBSERVED TO NOT HOLD PRESSURE. THE BALLOON WAS TAKEN OUT AND INFLATED OUTSIDE THE BODY, WHERE THE PHYSICIAN NOTICED A HOLE. ATHERECTOMY WAS PERFORMED WITH 2.0MM ROTABLATOR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9903723 ↗
• MalfunctionNov 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 3.0X220X150 STERLING BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9385233 ↗
• MalfunctionOct 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED TIBIAL VESSEL. A 3.0X220X150MM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240575 ↗
• MalfunctionOct 4, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DIFFICULTY DEFLATION OCCURRED. THE SIMPLE, DIFFUSE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 3.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER THE FIRST INFLATION AT NOMINAL PRESSURE, THE BALLOON WAS DIFFICULT TO DEFLATE. THE BALLOON WAS THEN SUCCESSFULLY DEFLATED AFTER EXCESSIVE EFFORTS OF MANUAL PULLING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7935115 ↗