Sterling™ H74939032504040Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 08714729122913), received between Sep 18, 2018 and Apr 2, 2026 — classified as 123 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (115 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SHUNT OF RIGHT FOREARM. A 5.0 MM X 40 MM X 40 CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE THIRD INFLATION FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 24763908 ↗
• MalfunctionMar 2, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24479995 ↗
• MalfunctionDec 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 6 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 23887757 ↗
• MalfunctionOct 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A SHUNT WITHIN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0 MM X 40 MM X 40 CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE SECOND INFLATION, AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389414 ↗
• MalfunctionSep 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATTER OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ARTERIOVENOUS GRAFT (AVG). A 5.0MMX40MMX40CM FG STERLING OTW WAS SELECTED FOR USE. DURING PREPARATION, PRIOR TO SEDATION, IT WAS NOTED THAT THERE WAS A DEBRIS IN THE HUB UPON UNPACKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126476 ↗
• MalfunctionAug 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED UPPER ARM VESSEL. A 5.0MMX40MMX40CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 14 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853924 ↗
• MalfunctionJun 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VESSEL. A 5.0 MM X 40 MM X 40 CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT 14 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 AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183310 ↗
• MalfunctionJun 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SHUNT. A 5.0 MM X 40 MM X 40 CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 22179080 ↗
• MalfunctionMay 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECOND. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 22032379 ↗
• MalfunctionMay 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE RIGHT FOREARM. A 5.0MMX40MMX40CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT THE MAXIMUM OF 10 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959061 ↗
• MalfunctionApr 28, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 5.0MMX40MMX40CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919850 ↗
• MalfunctionApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL OF LEFT FOREARM. A 5.0MMX40MMX40CM (4F) STERLING WAS ADVANCED FOR DILATION. DURING 2ND INFLATION AT AROUND 13-14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM AT THE BALLOON END. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 21917115 ↗
• MalfunctionAug 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 19891945 ↗
• MalfunctionJul 22, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY LEFT FOREARM VEIN. A 5.0MMX40MMX40CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION. THE DEVICE WAS NOT COMPLETED DUE TO SAME DEVICE UNAVAILABLE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEDATED WITH LOCAL ANESTHESIA WHEN THE ISSUE OCCURRED, AND THE PROCEDURE WAS COMPLETED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802204 ↗
• MalfunctionJul 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT FOREARM VEIN. A 5.0MMX40MMX40CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 19760371 ↗
• MalfunctionJun 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED FOREARM VESSEL. A 5.0MMX40MMX40CM STERLING BALLOON CATHETER WAS ADVANCE FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT 6 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH 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 19589201 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED INNER SHUNT. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED ONE TIME, AT 10 ATMOSPHERES FOR A FEW SECONDS, IT RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373936 ↗
• MalfunctionApr 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED SHUNT WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 5.0MMX40MMX40CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093836 ↗
• MalfunctionFeb 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0MMX40MMX40CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION BELOW THE NOMINAL PRESSURE, IT RUPTURED IMMEDIATELY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715052 ↗
• MalfunctionFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF LEFT FOREARM. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670630 ↗
• MalfunctionJan 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 18565060 ↗
• MalfunctionJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE LEFT FOREARM. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434394 ↗
• MalfunctionDec 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LEFT FOREARM. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED SEVERAL TIMES AT 14 ATMOSPHERES. AFTER THAT, THE BALLOON RUPTURED AT 12 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, 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 18251776 ↗
• MalfunctionAug 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE SEVERELY TORTUOUS AND NON-CALCIFIED VESSEL. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 5 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION POST PROCEDURE WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605641 ↗
• MalfunctionAug 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RADIAL VEIN. A 5.0MMX40MMX40CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561249 ↗