Sterling™ H74939031302010Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08714729755586), received between May 2, 2019 and Aug 14, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (38 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260561 ↗
• MalfunctionAug 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50156125 ↗
• MalfunctionMar 26, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL AND COMMON CAROTID ARTERIES. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT APPROXIMATELY 3 ATMOSPHERES, THE BALLOON RUPTURED. WHEN REMOVED, A PINHOLE WAS NOTED. 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 24698459 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13FEB2026. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID. A 3.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, IT WAS NOTED THAT THE BALLOON WAS LEAKING AND COULD NOT BE INFLATED. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BALLOON HAD A RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524711 ↗
• MalfunctionFeb 27, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS, 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 24469470 ↗
• MalfunctionJan 12, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 3.0MMX20MMX135CM (4F) STERLING WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE PRESSURE OF THE INFLATOR CONTINUED TO DROP, AND IT WAS OBSERVED THAT THE HEAD PART OF THE BALLOON WAS PERFORATED. 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 24037585 ↗
• MalfunctionSep 16, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 22AUG2025. IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE. THE STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 3.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON FAILED TO DILATE AFTER REACHING NOMINAL PRESSURE. IT WAS INFLATED TWICE FOR 15 SECONDS AT 6 ATMOSPHERES WITHOUT SUCCESSFUL DILATION. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED LONGITUDINAL TEAR IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067191 ↗
• MalfunctionJun 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED CEPHALIC ILIAC AND SUPERFICIAL FEMORAL ARTERY. A 3.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE THIRD INFLATION AT 6 ATMOSPHERES FOR SEVERAL 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 22130402 ↗
• MalfunctionJan 10, 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 LEFT SUPERFICIAL FEMORAL ARTERY. A 3.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER AT 10 ATMOSPHERES FOR 30 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 21123779 ↗
• MalfunctionDec 9, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ARTERY. A 3.0MMX20MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON WAS LEAKING. SUBSEQUENTLY, A BALLOON PINHOLE WAS NOTED AFTER THE INFLATION. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881127 ↗
• MalfunctionNov 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 6 ATMOSPHERES FOR SEVERAL SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 20768075 ↗
• MalfunctionOct 12, 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 POPLITEAL ARTERY. A 3.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 20435070 ↗
• MalfunctionMay 22, 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 BOTH SIDES OF THE COMMON ILIAC ARTERY TO EXTERNAL ILIAC ARTERY. AFTER INSERTING AN UNKNOWN WIRE AND ADVANCING AN UNKNOWN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER TO CONFIRM PASSAGE OF THE WIRE, THE IVUS CATHETER DID NOT PASS THROUGH THE LESION. THUS, A 2MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED WHEN INFLATED AT 10 ATMOSPHERES. BECAUSE OF THIS, ANOTHER COYOTE BALLOON CATHETER WAS USED BUT IVUS COULD NOT BE ADVANCED AGAIN DUE TO THE CALCIFICATION. THEREFORE, IT WAS DECIDED TO USE A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER TO DILATE THE LESION, HOWEVER, THE BALLOON RUPTURED UPON THE THIRD INFLATION AT 14 ATMOSPHERES. ANOTHER STERLING BALLOON CATHETER WAS THEN USED, AND DILATION WAS SUCCESSFULLY COMPLETED. AN UNKNOWN GUIDEWIRE WAS THEN ABLE TO PASS THROUGH AND THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF AN EPIC STENT. THERE WERE NO COMPLICATIONS, AND THE PATIENT RETURNED TO THE WARD AS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372946 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TOTALLY OCCLUDED STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT BELOW THE KNEE ARTERY. A 3.0MMX20MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS FINISHED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENTS CONDITION IS VERY GOOD AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531005 ↗
• MalfunctionDec 12, 2023Material 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 3.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 18309761 ↗
• MalfunctionNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 3.0MM X 20MM X 135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A 3X40 STERLING BALLOON CATHETER AND A STENT PLACEMENT OF A NON-BOSTON SCIENTIFIC DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18051898 ↗
• MalfunctionMar 24, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT RIGHT RENAL ANGIOGRAPHY, BALLOON DILATION AND RENAL ARTERY STENT IMPLANTATION. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, WHEN THE PRESSURE WAS INCREASED BY THE PUMP, THE DISTAL END OF THE BALLOON GOT BROKEN INSTANTANEOUSLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT IT WAS THE BALLOON OF THE DEVICE BURST AND NOT SHAFT BREAK AS PREVIOUSLY REPORTED. ALSO, THE STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RENAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613152 ↗
• MalfunctionJan 2, 2023Material 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 (SFA). A 3.0MM X 20MM X 135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16083152 ↗
• MalfunctionDec 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. ANOTHER 3.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED, BUT THE BALLOON ALSO RUPTURED DURING INFLATION. BOTH DEVICES WERE REMOVED, AND NO PORTIONS WERE LEFT BEHIND. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978677 ↗
• MalfunctionSep 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, 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 AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15449399 ↗
• MalfunctionAug 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL ARTERY. AFTER A NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH WAS INSERTED AND THE LESION CROSSED WITH NON-BSC GUIDEWIRE. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE DEVICE CROSSED THE LESION AND INITIAL INFLATION WAS PERFORMED AT 6 ATMOSPHERES IN 10 SECONDS; HOWEVER, THE BALLOON RUPTURED AT THE MIDDLE PART. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH NON-BSC DEVICE AND GOOD DILATION WAS OBTAINED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180045 ↗
• MalfunctionAug 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. A 3.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 14 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 NOR INJURIES REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15158827 ↗
• MalfunctionJul 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MMX20MMX135CM (4F) AND 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WERE USED IN THE SAME ORDER FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOONS RUPTURED VERTICALLY IN THE MIDDLE PART. THE BALLOONS WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099340 ↗
• MalfunctionJul 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 3.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946854 ↗
• MalfunctionApr 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 100% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. A 3.0MM X 20MM X 135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 12 ATMOSPHERES IN 10 SECONDS, THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14105104 ↗