Armada B2080-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648155437), received between Apr 3, 2018 and May 20, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (20 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT COMMON FEMORAL ARTERY WITH SEVERE STENOSIS AND MODERATE TORTUOSITY. THE 8 X 40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED TWICE TO 8 ATMOSPHERES AND RUPTURED. NO REPLACEMENT WAS USED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232411 ↗
• MalfunctionNov 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND 85% STENOSIS. THE 8X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED DURING THE FIRST INFLATION TO 14 ATMOSPHERES. ANOTHER ARMADA 35 PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536224 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 4ATMS. THEREFORE, THE BDC WAS REPLACED WITH A 8X40MM ARMADA 35 BDC, BUT AFTER BEING PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES, THE BALLOON WAS NOTED TO RUPTURE AT 2ATMS DURING THE FIRST INFLATION. AT THIS POINT, THE RUPTURED BDC WAS REMOVED AND A 7X40MM JADE BDC WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297229 ↗
• MalfunctionAug 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY. THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITHOUT USING ANOTHER DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700150 ↗
• MalfunctionJul 16, 2025Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY. A .018 GUIDEWIRE WAS ADVANCED AND THE 9.0X30MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED. THE .018 GUIDEWIRE WAS EXCHANGED FOR A .035 GUIDEWIRE TO GET MORE SUPPORT AND AN 8.0X40MM ARMADA 35 BALLOON WAS SUCCESSFULLY USED FOR POST DILATATION PER STANDARD PROCEDURE. BUT DURING ADVANCEMENT, THE BALLOON TOUCHED THE EDGE OF THE IMPLANTED STENT AND PUSHED THE IMPLANTED STENT SHORTENING/CRUSHING THE ABSOLUTE PRO VASCULAR STENT. ANOTHER 8.0X40MM ABSOLUTE PRO VASCULAR STENT WAS IMPLANTED TO EXTEND THE LENGTH OF THE PREVIOUSLY IMPLANTED ABSOLUTE PRO VASCULAR STENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523127 ↗
• MalfunctionMay 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SEVERELY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE RIGHT COMMON FEMORAL ARTERY. A 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, AND ADVANCED TO THE LESION WITHOUT RESISTANCE TO BE USED FOR VESSEL DILATATION; HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES THE BALLOON WAS NOTED TO RUPTURE. AT THIS POINT THE BDC WAS REMOVED AND A NEW 8X40MM ARMADA BDC WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THEREFORE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO NON-ABBOTT BALLOON CATHETERS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084476 ↗
• MalfunctionFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 8X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 15 ATMOSPHERES (ATM) AND RUPTURED. A SECOND 8X40 MM ARMADA 35 PTA CATHETER WAS INFLATED ONCE TO 15 ATM AND RUPTURED. A 12X40 MM ARMADA 35 PTA CATHETER RUPTURED DURING THE FIRST INFLATION TO 10 ATM. ANOTHER 12 MM ARMADA 35 PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326603 ↗
• MalfunctionFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 8X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 15 ATMOSPHERES (ATM) AND RUPTURED. A SECOND 8X40 MM ARMADA 35 PTA CATHETER WAS INFLATED ONCE TO 15 ATM AND RUPTURED. A 12X40 MM ARMADA 35 PTA CATHETER RUPTURED DURING THE FIRST INFLATION TO 10 ATM. ANOTHER 12 MM ARMADA 35 PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326479 ↗
• MalfunctionOct 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT COMMON ILIAC ARTERY WITH THE 8X40MM ARMADA 35 BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES (ATM), THEN A SECOND TIME TO 10ATM, WHEN A RUPTURE OCCURRED. ANOTHER 8X20MM ARMADA 35 PTA AND AN OMNI LINK STENT WERE USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523123 ↗
• MalfunctionOct 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON FEMORAL ARTERY. THE 8.0X40MM ARAMDA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE BDC WAS REMOVED AND ANOTHER ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465187 ↗
• MalfunctionApr 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, NOT TORTUOUS RIGHT EXTERNAL ILIAC ARTERY. THE 8.0X40MM ARMADA BALLOON WAS ADVANCED IN THE ANATOMY AND INFLATED; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072536 ↗
• InjuryApr 1, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION AND NO TORTUOSITY. THE 8X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO NOMINAL PRESSURE AND RUPTURED. NEGATIVE PRESSURE WAS HELD AFTER THE RUPTURE AND THE DEVICE WAS BEING REMOVED WHEN RESISTANCE WAS NOTED WITH THE ANATOMY. NEGATIVE PRESSURE WAS HELD TO CONFIRM THE BALLOON WAS FULLY DEFLATED; HOWEVER, THE BALLOON SEPARATED AND WAS SURGICALLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014082 ↗
• MalfunctionNov 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION RIGHT EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE 2ND INFLATION AFTER 30 SECONDS AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER ARMADA BALLOON WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18178195 ↗
• MalfunctionJan 13, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A LEFT EXTERNAL ILIAC ARTERY. AFTER THE 8.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS DELIVERED TO THE LESION AND WAS INFLATED THREE TIMES TO 4 AND 8 ATMOSPHERES TWICE. HOWEVER, IT WAS NOTED THE DEVICE WAS LOSING PRESSURE WHEN ATTEMPTING TO INFLATE. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159735 ↗
• MalfunctionSep 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 50% STENOSED LESION IN THE LEFT COMMON ILIAC ARTERY. THE ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INSIDE OF A STENT THAT WAS PREVIOUSLY IMPLANTED, AND NOW RESTENOSED. THE ARMADA 35 BALLOON WAS INFLATED ONE TIME TO 6 ATMOSPHERES (ATM) WHEN A RUPTURE OCCURRED. THE BDC WAS SIMPLY REMOVED, AND NO OTHER DEVICE WAS USED AFTER THE BALLOON RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432642 ↗
• MalfunctionJul 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE EXTERNAL ILIAC ARTERY. AFTER DEVICE PREPARATION PER INSTRUCTIONS FOR USE (IFU), THE 8.00X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, WITHOUT ISSUE, FOR LESION PRE-DILATATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 4 ATMOSPHERES (ATM). THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15016580 ↗
• InjuryApr 5, 2022Entrapment of Device; Difficult to Remove; Material Rupture; Material Separation; Entrapment of Device; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, DE NOVO LESION IN THE RIGHT COMMON FEMORAL ARTERY. AFTER AN UNSPECIFIED STENT WAS IMPLANTED IN THE RIGHT COMMON FEMORAL ARTERY, POST-DILATATION WAS BEING PERFORMED WITH AN 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), WHEN THE BALLOON RUPTURED DUE TO THE HEAVY CALCIFICATION AT THE LESION. THE BDC WAS THEN BEING REMOVED FROM THE ANATOMY WHEN IT BECAME STUCK WITH THE TIP OF THE SHEATH. IT WAS DECIDED THAT THE BDC AND SHEATH WOULD BE REMOVED FROM THE LESION AS A SINGLE UNIT, HOWEVER THE BALLOON BECAME STUCK IN CALCIUM, WHILE THE SHEATH WAS REMOVED INTACT. THE BDC BECAME SEPARATED, AND THE TIP OF THE DEVICE WAS LEFT INSIDE THE VESSEL. THE PATIENT WAS PUT UNDER GENERAL ANESTHESIA (GA), AND A CUT DOWN PROCEDURE WAS PERFORMED TO SUCCESSFULLY REMOVE THE RUPTURED BALLOON FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA, HOWEVER THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY DUE TO THE CUT DOWN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017391 ↗
• InjuryFeb 2, 2022Entrapment of Device; Material Rupture; Material Separation; Entrapment of Device; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT COMMON ILIAC ARTERY. AN 8X40MM ARMADA 35 BALLOON WAS ALREADY USED IN LEFT COMMON ILIAC AND INFLATED ONCE WITHOUT ISSUE. THEN IT WAS ADVANCED TO THE RIGHT COMMON ILIAC AND INFLATED ONCE AT 8 ATMOSPHERES, BUT BURST AT NOMINAL PRESSURE. AS THE DEVICE WAS BEING REMOVED, RESISTANCE WITH THE ANATOMY WAS MET AND THE BALLOON ITSELF SEPARATED. A SNARE WAS USED TO RETRIEVE THE SEPARATED BALLOON. NO PORTION OF THE DEVICE REMAINS IN THE PATIENT. NO FURTHER DEVICE WAS USED AS THE ARMADA 35 COMPLETED THE PROCEDURE BEFORE THE ISSUES OCCURRED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424266 ↗
• MalfunctionSep 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, SUBCLAVIAN ARTERY. THE 8 X 40 MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED TO 12 ATMOSPHERES (ATM). DURING DEFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. THE PROCEDURE WAS CONCLUDED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897620 ↗
• MalfunctionSep 20, 2018Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE DISTAL FEMORAL ARTERY. AN 8X40MM ARMADA 35 BALLOON CATHETER WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. THE BALLOON RUPTURED AT 18 ATMOSPHERES DURING THE FIRST INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895655 ↗
• MalfunctionApr 3, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED RIGHT ILIAC CORONARY ARTERY. THE 8.0X40MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THE BDC WAS REMOVED WITHOUT ISSUE AND ANOTHER 7.0X40MM X135CM ARMADA 35 BDC WAS ADVANCED WITHOUT ISSUE AND IT ALSO RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED STENT AND NEW ARMADA BDC WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7392506 ↗