Flexor G13009Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00827002130098), received between Jul 29, 2016 and Nov 6, 2025 — classified as 12 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488174 ↗
• MalfunctionOct 24, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 06NOV2025. THE PROCEDURE INVOLVED INTERVENTION OF THE RIGHT LEG, VIA CONTRALATERAL ¿UP AND OVER¿ ACCESS FROM THE LEFT SIDE. THE ACCESS SITE WAS ¿SOMEWHAT¿ SCARRED, AND THE ANATOMY, INCLUDING THE AORTIC BIFURCATION, WAS CALCIFIED. ANOTHER MANUFACTURER¿S 0.035-INCH WIRE WAS USED DURING THE PROCEDURE, AND ANOTHER MANUFACTURER¿S ANGLED GLIDE CATHETER WAS ALSO USED THROUGH THE SHEATH. RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE SHEATH, AS WELL AS DURING INSERTION OF ANOTHER MANUFACTURER¿S 0.018-INCH WIRE AND ANOTHER MANUFACTURER¿S BALLOON THROUGH THE SHEATH. RESISTANCE WAS ALSO ENCOUNTERED DURING REMOVAL OF THE SHEATH; HOWEVER, THE USER DID NOT REINSERT THE DILATOR PRIOR TO SHEATH REMOVAL. A WIRE WAS IN THE SHEATH LUMEN AT THE TIME OF SEPARATION. A SNARE WAS USED TO REMOVE THE SEPARATED SHEATH, AND THE INTERVENTION WAS STOPPED. ALTHOUGH THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY, THERE WAS REPORTEDLY NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378532 ↗
• MalfunctionSep 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE DEVICE AS IT WAS BEING EXCHANGED OVER AN UNSPECIFIED WIRE GUIDE. THE HUB OF A FLEXOR RAABE GUIDING SHEATH FROM ANOTHER LOT ALSO SEPARATED DURING THE PROCEDURE, WHICH WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23117510 ↗
• MalfunctionSep 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE DEVICE AS IT WAS BEING EXCHANGED OVER AN UNSPECIFIED WIRE GUIDE. THE HUB OF A FLEXOR RAABE GUIDING SHEATH FROM ANOTHER LOT ALSO SEPARATED DURING THE PROCEDURE, WHICH WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23112864 ↗
• InjuryJun 11, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 10JUN2025. THE 6-FRENCH SHEATH WAS UNABLE TO CROSS A CALCIFIED LESION IN THE RIGHT ILIAC ARTERY; HOWEVER, THE 5-FRENCH COMPLAINT DEVICE WAS ABLE TO CROSS THE LESION. THE BIFURCATION WAS NOT STEEP OR CALCIFIED. ANOTHER MANUFACTURER¿S STIFF WIRE AND CUTTING BALLOON WERE USED THROUGH THE SHEATH. RESISTANCE WAS ENCOUNTERED AS BALLOONS WERE PASSED THROUGH THE CALCIFIED AREA, AS WELL AS DURING INSERTION OF BALLOONS INTO THE SHEATH. THE SHEATH SEPARATED APPROXIMATELY MID-SHAFT. REPORTEDLY, THE USER WAS ¿ABLE TO SUCCESSFULLY FIX A LESION IN THE VESSEL DISTAL TO THE CALCIFIED LESION IN THE RIGHT ILIAC ARTERY¿, SUCCESSFULLY COMPLETING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22186070 ↗
• MalfunctionMar 13, 2025Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF AN ARTERIAL OCCLUSION IN THE LEFT LEG, A FLEXOR RAABE GUIDING SHEATH UNRAVELED AND SEPARATED. CONTRALATERAL ACCESS WAS OBTAINED WITH A MICROPUNCTURE KIT. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE ANATOMY WAS CALCIFIED. THE BIFURCATION WAS REPORTEDLY NOT STEEP OR CALCIFIED. ANOTHER MANUFACTURER¿S 0.035-INCH WIRE WAS USED DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. AFTER BALLOON DILATION OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE USER ATTEMPTED TO PULL THE SHEATH BACK BY PULLING FROM THE HUB; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE SHEATH WAS DIFFICULT TO REMOVE. THEREFORE, THE PHYSICIAN USED MORE FORCE TO REMOVE THE DEVICE, AT WHICH POINT THE SHEATH UNRAVELED AND SEPARATED. REPORTEDLY, THE DILATOR WAS REINSERTED PRIOR TO ATTEMPTED REMOVAL OF THE SHEATH. THE SEPARATED SHEATH WAS REMOVED ¿ENDOVASCULARLY¿, AND AN UNSPECIFIED 90-CENTIMETER SHEATH WAS USED TO COMPLETE THE PROCEDURE BELOW-THE-KNEE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21598397 ↗
• InjuryOct 16, 2024Break; Break

  AS REPORTED, AT THE END OF AN UNSPECIFIED ¿LEG CASE¿ VIA COMMON FEMORAL ACCESS, A FLEXOR RAABE GUIDING SHEATH SEPARATED AT THE SHAFT UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE DILATOR WAS NOT IN PLACE AT THE TIME OF THE EVENT. THE PROCEDURE HAD ALREADY BEEN SUCCESSFULLY COMPLETED WITH THE COMPLAINT DEVICE. THE PATIENT WAS HOSPITALIZED, AND A SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE SEPARATED DEVICE FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464417 ↗
• MalfunctionAug 9, 2024Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951710 ↗
• MalfunctionJul 2, 2024Break; Unraveled Material; Break; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 08JUL2024. CONTRALATERAL ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY AND THE SHEATH WAS ADVANCED TO THE LEFT COMMON FEMORAL ARTERY. THE ANATOMY WAS CALCIFIED AND MILDLY TORTUOUS, AND THE VESSELS WERE UNHEALTHY. IT IS UNKNOWN IF THE AORTIC BIFURCATION WAS STEEP OR CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OF THE DEVICE. AT THE END OF THE CASE, AFTER TREATMENT WAS FINISHED AND THE USER ATTEMPTED TO CLOSE THE ARTERY, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AS THE USER ATTEMPTED TO EXCHANGE THE COMPLAINT DEVICE FOR AN UNSPECIFIED SHORT SHEATH, OVER AN UNSPECIFIED STIFF GUIDE WIRE. THE DILATOR WAS NOT REINSERTED PRIOR TO ATTEMPTED REMOVAL OF THE SHEATH, WHICH UNRAVELED/SEPARATED. THE UNRAVELED SHEATH WAS MANUALLY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655387 ↗
• InjuryOct 30, 2023Break; Unraveled Material; Break; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 07NOV2023. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TARGET A BYPASS GRAFT IN THE PROXIMAL-TO-MID LEFT THIGH. THE ACCESS SITE WAS NOT SCARRED AND THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED; HOWEVER, THE AORTIC BIFURCATION WAS STEEP. RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF ANOTHER MANUFACTURER'S FOUR-MILLIMETER BALLOON CATHETER THROUGH THE SHEATH. BECAUSE RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE BALLOON CATHETER FROM THE SHEATH, THE BALLOON AND SHEATH WERE REMOVED TOGETHER, LOSING WIRE ACCESS. REPORTEDLY, THE SHEATH WAS "ACCORDIONED" AND STRETCHED OUT UPON REMOVAL. THE DEVICES WERE REMOVED UNDER FLUOROSCOPY TO ENSURE THE DEVICES DID NOT COMPLETELY SEPARATE. ONCE THE BALLOON WAS FAR ENOUGH OUT OF THE BODY, BUT STILL WITHIN THE SHEATH, THE USER CUT THE SHEATH AT THE LEVEL OF THE GROIN ACCESS SITE AND PLACED ANOTHER WIRE THROUGH THE SHEATH. THE TIP OF THE SHEATH WAS JUST ACROSS THE BIFURCATION IN THE COMMON ILIAC ARTERY. THE ENTIRE SYSTEM WAS THEN REMOVED OVER THE WIRE GUIDE. ACCESS WAS THEN OBTAINED WITH A 6-FRENCH SHEATH. THE BYPASS GRAFT REPORTEDLY RUPTURED

  Patient problems: Perforation of Vessels; Rupture; Unspecified Vascular Problem

  MAUDE report 18030594 ↗
• InjuryJul 21, 2023Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A FLEXOR RAABE GUIDING SHEATH SEPARATED IN HALF UPON REMOVAL OF THE DEVICE. THE GROIN ACCESS SITE WAS VERY SCARRED. AN UNKNOWN 4-MILLIMETER BALLOON WAS USED THROUGH THE SHEATH DURING THE PROCEDURE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE DEVICE. THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL CENTER FOR SURGICAL REMOVAL OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17370623 ↗
• InjuryJun 22, 2023Break; Stretched; Unraveled Material; Break; Stretched; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 29JUN2023. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TARGET THE LEFT COMMON FEMORAL ARTERY. THE ACCESS SITE WAS SCARRED FROM PREVIOUS VASCULAR SURGERY; HOWEVER, THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE BIFURCATION WAS NOT STEEP OR CALCIFIED. ANOTHER MANUFACTURER'S 0.035-INCH WIRE WAS USED DURING THE PROCEDURE AND WAS IN PLACE AT THE TIME OF SHEATH SEPARATION. RESISTANCE WAS NOT REPORTED DURING MANIPULATION OF OTHER DEVICES THROUGH THE SHEATH; HOWEVER, RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH FROM THE PATIENT. THE DILATOR WAS NOT REINSERTED PRIOR TO SHEATH REMOVAL. APPROXIMATELY TEN CENTIMETERS OF THE SHEATH TIP SEPARATED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH WAS SEPARATED, UNRAVELED, AND STRETCHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17184561 ↗
• MalfunctionJan 18, 2023Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 17MAR2023. THE FLEXOR RAABE GUIDING SHEATH WAS USED DURING A LOWER EXTREMITY ANGIOGRAM, PERFORMED IN A CATHETERIZATION LAB UNDER MONITORED SEDATION. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY (CFA) PROXIMAL TO THE BIFURCATION, USING A MICROPUNCTURE DEVICE. THE LEFT COMMON FEMORAL ARTERY AND FEMORAL BIFURCATION WERE NOTED TO BE LARGELY FREE OF DISEASE, PER ULTRASOUND FINDINGS. RESISTANCE WAS NOT NOTED DURING ACCESS. THE PUNCTURE SITE WAS ENLARGED WITH A #11 SCALPEL AND THE ACCESS SITE WAS SERIALLY DILATED PRIOR TO INSERTION OF A 5FRENCH, 10-CENTIMETER SHEATH OVER A 0.035-INCH WIRE. THE USER NOTED THAT SERIAL DILATION WAS VERY DIFFICULT DUE TO SIGNIFICANT SCAR TISSUE IN THE LEFT GROIN, REQUIRING ONE PASS OF EACH DILATOR BEFORE THE SHEATH COULD BE ADVANCED OVER THE WIRE. USING FLUOROSCOPY, THE WIRE WAS ADVANCED INTO THE ABDOMINAL AORTA AND A FLUSH CATHETER WAS USED TO PERFORM ANGIOGRAPHY OF THE AORTA AND BILATERAL ILIAC ARTERIES. BLOOD FLOW WAS NOTED TO BE PATENT THROUGH THE ABDOMINAL AORTA AND THE BILATERAL COMMON, INTERNAL, AND EXTERNAL ILIAC ARTERIES WITHOUT SIGNIFICANT FOCAL STENOSIS; HOWEVER, THE BILATERAL COMMON IL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195157 ↗
• MalfunctionFeb 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE DEVICE UPON WITHDRAWAL OF THE DEVICE FROM THE PATIENT. A NEW SHEATH WAS USED TO CONTINUE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13471976 ↗
• MalfunctionDec 27, 2021Break; Material Separation; Break; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 13087306 ↗
• MalfunctionAug 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED 20SEP2021. THE PROCEDURE PERFORMED WAS LOWER EXTREMITY ANGIOPLASTY. THE ACCESS SITE WAS THE FEMORAL UP AND OVER. "MINOR" BLOOD LOSS TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12323976 ↗
• MalfunctionAug 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316991 ↗
• MalfunctionJun 18, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024653 ↗
• MalfunctionApr 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628516 ↗
• MalfunctionNov 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM, ATHERECTOMY, AND ANGIOPLASTY OF THE LEFT LEG, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE SHAFT UPON REMOVAL OF THE DEVICE FOR A SHEATH EXCHANGE. THE USER WAS WITHDRAWING THE SHEATH USING A PUSH/PULL MOTION AND ENCOUNTERED RESISTANCE. THE ACCESS SITE WAS STABILIZED DURING REMOVAL. WHEN THE SHEATH WAS APPROXIMATELY HALFWAY OUT OF THE PATIENT, THE HUB SEPARATED FROM THE SHAFT. THE SHAFT WAS PULLED OUT BY THE PHYSICIAN IN ITS ENTIRETY, AND WAS IMMEDIATELY EXCHANGED FOR ANOTHER SHEATH. THE DILATOR WAS NOT IN THE SHEATH AT THE TIME OF REMOVAL OR SEPARATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10795415 ↗
• InjuryNov 3, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  AS REPORTED, AT THE COMPLETION OF AN ANGIOGRAM OF THE LEFT LEG, THE HUB AND SHAFT OF A FLEXOR RAABE GUIDING SHEATH SEPARATED UPON ATTEMPTED REMOVAL OF THE DEVICE FROM THE PATIENT. THE (B)(6) PATIENT HAD AN INFECTED ULCER OF THE LEFT SECOND TOE AND POSSIBLE OSTEOMYELITIS. IN ADDITION, HE HAD A HISTORY OF TYPE II DIABETES, STAGE THREE KIDNEY DISEASE, A CEREBROVASCULAR ACCIDENT, AND AN ABOVE-THE-KNEE AMPUTATION OF THE RIGHT LEG. THE PATIENT WAS BOUND TO A WHEELCHAIR. THE GROINS WERE SCARRED BILATERALLY, AND THE AORTIC BIFURCATION WAS STEEP, WITH ILIAC STENTS IN PLACE. ACCESS WAS OBTAINED IN THE SCARRED RIGHT GROIN AND INSERTION OF THE DEVICE WAS ¿RELATIVELY EASY¿. ANOTHER MANUFACTURER¿S ATHERECTOMY DEVICE WAS USED THROUGH THE SHEATH DURING THE PROCEDURE. AT THE END OF THE PROCEDURE, WHICH LASTED APPROXIMATELY NINETY MINUTES, THE USER ATTEMPTED TO PULL THE DEVICE FROM THE PATIENT; HOWEVER, THE HUB SEPARATED FROM THE DEVICE. BLOOD LOSS WAS ESTIMATED AT 200 MILLILITERS; HOWEVER, ADMINISTRATION OF BLOOD PRODUCTS WAS NOT REQUIRED. AT THAT POINT, THE USER ATTEMPTED TO REINSERT THE DILATOR, BUT IT COULD NOT BE FULLY INSERTED. THE PHYSICIAN CONTINUED TO PULL ON THE SHEATH WHEN A SNAP WAS FELT

  Patient problems: No Code Available

  MAUDE report 10781566 ↗
• MalfunctionSep 12, 2019Material Separation; Material Separation

  AS REPORTED, DURING PERIPHERAL INTERVENTION OF THE ARTERIES IN THE LEG, A FLEXOR RAABE GUIDING SHEATH SEPARATED INTO THREE PIECES UPON REMOVAL OF THE DEVICE. THE DEVICE WAS REMOVED WITH THE AID OF A GUIDEWIRE AND CLAMPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9009873 ↗
• InjurySep 3, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 8955137 ↗
• MalfunctionAug 28, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8939658 ↗
• MalfunctionAug 10, 2019Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  SEE H10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8881668 ↗