Armada A2025-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08717648156045), received between Apr 30, 2018 and May 29, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PERONEAL ARTERY WITH MODERATE CALCIFICATION. THE 2.5X120 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED THREE TIMES AND RUPTURED AT 8 ATMOSPHERES. A 2.5X80 MM BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333991 ↗
• MalfunctionJun 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 2.5X120 MM ARMADA 14 WAS PREPARED ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE. IT WAS ADVANCED TO THE HEAVILY CALCIFIED, 90% STENOSIS IN THE ANTERIOR TIBIAL ARTERY. THE ARMADA RUPTURED AT AN UNKNOWN PRESSURE. ANOTHER ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134888 ↗
• MalfunctionMay 30, 2025Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT PERONEAL ARTERY. THE 2.5X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED ON THE PROCEDURE WITHOUT ISSUE; HOWEVER, DURING REMOVAL OF THE BDC RESISTANCE WAS FELT WITH THE TIP OF THE SHEATH. THEREFORE, THE BDC, SHEATH AND GUIDE WIRE REMOVED AS A SINGLE UNIT. AFTER REMOVAL THE BALLOON WAS NOTED TO BE LOOSELY FOLDED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118061 ↗
• MalfunctionMay 16, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5X120MM ARMADA 14 BALLOON DILATATION CATHETER, THE DEVICE KEPT PULLING AIR. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037534 ↗
• MalfunctionOct 7, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH MILD CALCIFICATION. DURING INFLATION OF THE 2.5X120 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER TO 10 ATMOSPHERES, A RUPTURE WAS NOTED AS THE DEVICE WOULD NOT INFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 20386134 ↗
• MalfunctionSep 19, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THE 2.5X120 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER LEAKED AT THE HUB DURING PREP. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258232 ↗
• MalfunctionSep 10, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY (ATA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. A COMMAND ES GUIDE WIRE CROSSED THE LESION AND THEN THE 2.5X120 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION. UPON INFLATION TO NOMINAL PRESSURE, THE BALLOON DID NOT EXPAND TO ITS COMPLETE PROFILE AND A LEAK WAS NOTED AT THE HUB. A 2.5X200 MM ARMADA 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 20185229 ↗
• MalfunctionApr 10, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE TIBIAL ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ON A COMMAND ES GUIDEWIRE (GW) TO THE TARGET LESION. THE BALLOON WAS ATTEMPTED TO BE INFLATED MULTIPLE TIMES; HOWEVER, THE BALLOON DID NOT INFLATE AS A LEAK WAS NOTED AT THE HUB OF THE BDC. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER 2.5X120MM ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083288 ↗
• MalfunctionMar 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE POSTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A 3X120MM ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890248 ↗
• MalfunctionMar 6, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, MODERATELY CALCIFIED, MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY LESION. AFTER CROSSING THE TARGET LESION WITH A 2.5MM X 120MM ARMADA BALLOON DILATATION CATHETER (BDC) AND A COMMAND GUIDE WIRE, THE BDC WOULD ONLY PARTIALLY INFLATE WHEN PRESSURIZED TO NOMINAL PRESSURE. A LEAK IN THE HUB WAS NOTED. ANOTHER 3.0MMX120MM ARMADA 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 18844994 ↗
• MalfunctionOct 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 2.5X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 2.5X120MM ARMADA 14 BDC. 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 17891630 ↗
• MalfunctionJul 13, 2023Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL TIBIAL TRUNK (DTIBIAL TRUNK) WITH MODERATE CALCIFICATION AND NONE TORTUOSITY. THE 2.25X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE AT 4 ATMOSPHERES WHEN THE BALLOON STOPPED HOLDING PRESSURE; THEREFORE, WAS REMOVED. ANOTHER ARMADA 14 PTA 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 17317244 ↗
• MalfunctionMar 29, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION THE 2.50X120MM ARMADA BALLOON DILATATION CATHETER (BDC) CONTINUED TO DRAW AIR WHILE HOLDING NEGATIVE PRESSURE. A HOLE IN THE BALLOON WAS SUSPECTED. THEREFORE THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER BALLOON WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640359 ↗
• MalfunctionMar 15, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PREPARATION THE 2.5/120 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED AND THE DEVICE WOULD NOT FILL UP PRIOR BEING USED ON THE PATIENT. ANOTHER ARMADA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, 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 16546555 ↗
• MalfunctionMar 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 2.5MMX120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 6 ATMOSPHERES (ATM). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535087 ↗
• MalfunctionDec 29, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 2.50X120MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS TO TREAT A LESION IN THE PERONEAL ARTERY. THE BDC WAS ADVANCED TO THE TARGET LESION AND ATTEMPTED TO BE INFLATED; HOWEVER THE BALLOON WOULD NOT STAY INFLATED AND A HUB LEAK WAS NOTED. THEREFORE THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME SIZE ARMADA BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16072914 ↗
• MalfunctionJun 3, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE, PERFORMED TO TREAT A TARGET LESION IN THE MINIMALLY STENOSED AND TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY, OCCLUDED MOSTLY WITH CLOT. THE 2.5 X 120 MM ARMADA 14 DILATATION CATHETER WAS INFLATED TWICE, TO 10 ATMOSPHERES, WITHOUT ISSUE. DURING DEFLATION, THE BALLOON PARTIALLY DEFLATED. NO ADDITIONAL INTERVENTION WAS PERFORMED TO FULLY DEFLATE THE ARMADA BALLOON. THE DEVICE WAS PULLED BACK INTO THE SHEATH AND THEN DEFLATED. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596842 ↗
• MalfunctionNov 18, 2021Product Quality Problem; Material Rupture; Product Quality Problem; Material Rupture

  IT WAS REPORTED THAT PRIOR TO INSERTING THE 2.50X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) INTO THE SHEATH, IT WAS NOTED THE BALLOON LOOKED IRREGULAR, LIKE IT HAD A BUBBLE. THE BDC WAS NOT USED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836561 ↗
• MalfunctionOct 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERIPHERAL PERCUTANEOUS INTERVENTION ON THE PERONEAL ARTERY, CALCIFIED LESION. AN ARMADA BALLOON CATHETER ADVANCED TO THE LESION SITE WITHOUT AN ISSUE REPORTED. DILATATION WAS PERFORMED AT 8 ATMOSPHERES WHEN THE BALLOON BURST. THE DEVICE WAS REMOVED WITHOUT ISSUE. ANOTHER ARMADA DILATATION CATHETER ADVANCED TO THE LESION WITHOUT AN ISSUE NOTED. DURING BALLOON DILATATION AT 10 ATMOSPHERES, THIS BALLOON ALSO BURST. THE DEVICE WAS REMOVED WITHOUT FURTHER ISSUES. ANOTHER ARMADA CATHETER WAS SUCCESSFULLY USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615692 ↗
• MalfunctionJan 11, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID POSTERIOR TIBIAL ARTERY. POST ATHERECTOMY, THE 2.5X120 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED, BUT RUPTURED AT 18 ATMOSPHERES. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152177 ↗
• MalfunctionFeb 27, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BOX FOR AN ARMADA 14 WAS PULLED AND JUST BEFORE USE, THE DEVICE WAS NOTED TO BE AN ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE DISCREPANCY WAS NOTED BEFORE USE AND THE DEVICE WAS NOT USED. A NEW DEVICE WAS PULLED AND WAS ABLE TO BE SUCCESSFULLY USED. REPORTEDLY, THE ACCOUNT MAY HAVE INADVERTENTLY PLACED THE WRONG DEVICE IN THE BOX BUT THAT COULD NOT BE CONFIRMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9766136 ↗
• MalfunctionJan 31, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE TIBIAL ARTERY. THE ARMADA BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND DURING BALLOON INFLATION AT 3 ATMOSPHERES, A LEAK WAS NOTED AT THE TIP OF THE DEVICE. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655391 ↗
• MalfunctionSep 17, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WOULD NOT INFLATE BECAUSE IT WAS PUNCTURED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9078533 ↗
• MalfunctionSep 6, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY. THE 2.5X120 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION OVER A 0.014 INCH GUIDE WIRE. IT WAS ATTEMPTED TO INFLATE THE CATHETER; HOWEVER, IT WOULD NOT INFLATE AT ALL. TWO INFLATIONS WERE ATTEMPTED BUT THE DEVICE WAS LOSING PRESSURE. THE PTA CATHETER WAS REMOVED AND INSPECTED AND THE PHYSICIAN NOTED A LEAK [RUPTURE]. ANOTHER 2.5X80 MM ARMADA 14 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 Consequences Or Impact To Patient

  MAUDE report 8972860 ↗
• MalfunctionJul 11, 2019Material Rupture; Failure to Advance; Difficult to Advance; Material Rupture; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATE TO SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 2.5X120MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED WITH LIGHT RESISTANCE DUE TO THE ANATOMY AND DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 4 OR 6 ATMOSPHERES. AN UNSPECIFIED BALLOON CATHETER WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 8781697 ↗