MINI TREK™ 1012270-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648138133), received between Sep 1, 2016 and Mar 25, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 2X8 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND RUPTURED. ANOTHER TREK BALLOON 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 24691587 ↗
• MalfunctionFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 85% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD TORTUOSITY. THE 2X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 4 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. 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 24312884 ↗
• MalfunctionNov 18, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATATION, THE 2X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK BDC WAS USED TO CONTINUE 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 23586644 ↗
• MalfunctionNov 6, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE 2.00 X 8MM MINI TREK RX WAS TO BE USED IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). RESISTANCE WAS FELT WITH THE LESION WHEN ADVANCING THE BALLOON TO THE TARGET SITE. THE MINI TREK RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE MINITREK WAS REMOVED AND ANOTHER TREK BALLOON 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 23491643 ↗
• MalfunctionJul 9, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 2.0X08MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. 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 22457180 ↗
• MalfunctionJul 2, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT CIRCUMFLEX (CX). A 2.0X8MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE WITH THE ANATOMY. HOWEVER DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8 ATMS. THEREFORE THE BDC WAS REPLACED WITH ANOTHER UNKNOWN DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386857 ↗
• MalfunctionFeb 12, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATATION, THE 2X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE THE ANATOMY. THE BALLOON WAS INFLATED TO 6 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK BALLOON WAS USED TO CONTINUE 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 21364011 ↗
• MalfunctionNov 11, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA) THAT IS 90% STENOSED. A 2.0X8MM MINI TREK CORONARY DILATATION CATHETER MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT. ONCE AT THE LESION THE MINK TREK RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. A NEW MINI TREK WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20659300 ↗
• MalfunctionOct 3, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00X8MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS SUCCESSFULLY USED FOR PRE-DILATATION AND INFLATED TO 12 ATMOSPHERES. AFTER THE BDC WAS DEFLATED, DURING REMOVAL RESISTANCE WAS MET WITH THE ANATOMY AND THE BALLOON SEPARATED FROM THE SHAFT AND WAS TRAPPED INSIDE THE INTRODUCER SHEATH. THE SHEATH ALONG WITH THE SEPARATED BALLOON WERE SIMPLY REMOVED AND A NON-ABBOTT DEVICE 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 20358146 ↗
• MalfunctionAug 8, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY. THE 2.0X8MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TREK. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938610 ↗
• MalfunctionJun 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION AND THE BALLOON WAS INFLATED ONCE; HOWEVER, THE BALLOON RUPTURED AT 10 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. A NC TREK NEO BDC WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472188 ↗
• MalfunctionDec 8, 2023Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTRAL RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. REPORTEDLY, A MINI TREK RX 2.00 X 8MM BALLOON WAS INFLATED BUT RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER NC TREK WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS RESISTANCE WITH THE LESION DURING ADVANCEMENT AND REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293264 ↗
• MalfunctionMay 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. A 190CM HT BMW UNIVERSAL II GUIDE WIRE (GW) WAS OPENED FOR USE WHEN IT WAS NOTICED THAT THE TIP OF THE WIRE WAS KINKED. THE GUIDE WIRE WAS NOT USED IN THE PATIENT. A NEW BMW WAS USED FOR THE PROCEDURE WITHOUT ISSUE. A 2.0X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE AND RUPTURED ON THE FIRST INFLATION TO UNKNOWN ATMOSPHERES (ATM). A NEW MINI TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954578 ↗
• MalfunctionDec 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO USE, THE 2.00X8MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THE PROCEDURE WAS TO TREAT A 90 % STENOSED LESION IN LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE BDC WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE; HOWEVER THE BALLOON RUPTURED. THE BDC WAS REMOVED FROM THE PATIENT, WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921111 ↗
• MalfunctionNov 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN REMOVING THE 2.0X18MM MINI TREK BALLOON DILATATION CATHETER (BDC) FROM THE PACKAGING IT WAS NOTED TO BE SEPARATED INTO TWO PIECES AT THE MID SHAFT. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER 2.0 MINI TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789823 ↗
• MalfunctionJan 17, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST DIAGONAL CORONARY ARTERY. THE 2.0X8 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT COULD NOT CROSS THE LESION. DURING INDEPENDENT REMOVAL THERE WAS RESISTANCE WITH THE ANATOMY. A NON-ABBOTT BALLOON 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 13268803 ↗
• MalfunctionNov 10, 2021Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE TORTUOUS OBTUSE MARGINAL (OM) CORONARY ARTERY. THE MINI TREK BALLOON CATHETER WAS ADVANCED BUT HAD DIFFICULTIES CROSSING THE LESION DUE TO THE PATIENT ANATOMY. AFTER MULTIPLE ATTEMPTS TRYING TO CROSS THE LESION, THE BALLOON CROSSED AND THE BALLOON WAS INFLATED WITHOUT ISSUE. DURING REMOVAL OF THE BALLOON CATHETER INTO A NON-ABBOTT GUIDING CATHETER, THERE WAS NO REPORTED RESISTANCE. BUT THE PROXIMAL SHAFT SEPARATED IN THE GUIDING CATHETER. THE SEPARATED PORTION WAS EASILY REMOVED FROM THE GUIDING CATHETER. THERE WERE NO PATIENT EFFECTS REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788022 ↗
• MalfunctionSep 16, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, HEAVILY TORTUOUS AND MODERATELY CALCIFIED, CONCENTRIC LESION IN THE LEFT DIAGONAL CORONARY ARTERY. THE VESSEL DIAMETER WAS 2.0MM AND THE LESION LENGTH WAS 18MM. THE 2.0X8MM MINI TREK RX BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE TO RESISTANCE WITH THE ANATOMY. DILATATION WAS PERFORMED TWICE; HOWEVER, THE BDC COULD STILL NOT CROSS THE LESION. RESISTANCE WITH THE ANATOMY WAS FELT DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SMALLER NON-ABBOTT BALLOON. THERE WERE NO REPORTED 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 10541135 ↗
• MalfunctionMar 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DO NOVO, MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.0X8 MM TREK BALLOON DILATATION CATHETER (BDC) CROSSED THE LESION AND WAS INFLATED TO 12 ATMOSPHERES FOR 20 SECONDS AND RUPTURED. REPORTEDLY, THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL. A NON-ABBOTT BDC WAS USED TO CONTINUE 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 9802721 ↗
• MalfunctionJul 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT BEFORE INTRODUCING THE BALLOON INTO THE GUIDING CATHETER, THE PHYSICIAN NOTED THAT THE SHAFT OF THE 2.00X8 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS SEPARATED. THE BDC NEVER ENTERED THE PATIENT ANATOMY AND WAS EASILY REPLACED WITH ANOTHER, SAME SIZE MINI TREK BDC. 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 8827867 ↗
• MalfunctionJul 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.80X08MM RX MINI TREK BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION WITH NO RESISTANCE. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITH NO RESISTANCE AND REPLACED WITH A SAME SIZE NON-ABBOTT BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818725 ↗
• MalfunctionJan 17, 2018Material Rupture; Improper or Incorrect Procedure or Method

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7202280 ↗
• MalfunctionSep 1, 2016Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CORONARY LESION LOCATED IN THE POSTERIOR DESCENDING ARTERY THAT WAS MILDLY CALCIFIED AND MILDLY TORTUOUS. WHEN THE MINI TREK 2.0 X 8.0 MM BALLOON DILATATION CATHETER (BDC) WAS PRESSURIZED FOR THE FIRST TIME AT 5 ATMOSPHERES, THE BALLOON INFLATED, BUT IT KEPT LOSING PRESSURE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE MINI TREK BDC. 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 5922734 ↗