Flexor G31138Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00827002311381), received between Dec 9, 2016 and Oct 29, 2025 — classified as 1 death, 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Flaked; Flaked

  AS REPORTED, UNSPECIFIED COOK FLEXOR SHUTTLE LONG SHEATHS WERE USED FOR THREE CASES INVOLVING PLACEMENT OF NEUROVASCULAR FLOW-DIVERTING STENTS WITHIN THE PAST SIX YEARS, AFTER WHICH THE PATIENTS DEVELOPED IATROGENIC GRANULOMATOUS INFLAMMATORY REACTIONS TO HYDROPHILIC COATING MATERIAL EMBOLIZATION. THE THREE CASES WILL BE REPORTED UNDER PATIENT IDENTIFIERS (B)(6). ANOTHER MANUFACTURER¿S CATHETERS WERE ALSO USED DURING THE PROCEDURES, AS WELL AS UNSPECIFIED STENTS. A FEW WEEKS AFTER THE PROCEDURES, THE PATIENTS DEVELOPED NEUROLOGICAL DEFICITS, SECONDARY TO MULTIPLE TINY NODULES OF INFLAMMATION IN THE AREA OF THE BRAIN SUPPLIED BY THE ARTERIES INVOLVED IN THE PROCEDURES. REPORTEDLY, THE USER BELIEVES THAT SOME OF THE COATING MATERIAL OF ANY OF THE DEVICES USED DURING THE PROCEDURES MAY HAVE DETACHED AND EMBOLIZED DISTALLY, CAUSING INFLAMMATION IN SENSITIVE PATIENTS. PER THE REPORTER, THE COATING OF THE UNKNOWN STENT IS NOT BELIEVED TO BE THE CULPRIT IN ALL THREE CASES, AS ONE CASE ALSO INVOLVED TERRITORY OF BRANCHES PROXIMAL TO THE LOCATION OF THE STENT. THE USER SUSPECTS THAT THE EMBOLIZED PARTICLES MAY HAVE ORIGINATED FROM THE SHEATH OR OTHER MANUFACTURER¿S GUIDING CATHETERS, WHICH

  Patient problems: Dizziness; Foreign Body In Patient; Granuloma; Muscle Weakness/Atrophy; Unspecified Nervous System Problem

  MAUDE report 23417044 ↗
• MalfunctionSep 16, 2025Fluid/Blood Leak; Unraveled Material; Fluid/Blood Leak; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING REPAIR OF AN ANEURYSM IN THE BRAIN, THE HUB OF A FLEXOR SHUTTLE SELECT GUIDING SHEATH LEAKED. THE DEVICE WAS INSERTED INTO THE RIGHT GROIN OVER AN UNSPECIFIED 145-CENTIMETER BENTSON WIRE. WHEN THE WIRE WAS REMOVED AND THE DEVICE WAS FLUSHED, BLOOD LEAKED BELOW THE SHEATH HUB. PER THE REPORTER, THE TUOHY-BORST HAD BEEN REMOVED WHEN THE LEAK WAS NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND ANOTHER SHEATH WAS USED WITHOUT PROBLEMS. 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 23061883 ↗
• InjuryJul 1, 2025Break; Break

  AS REPORTED, DURING A RUNOFF ANGIOGRAM WITH TIBIAL ATHERECTOMY, A FLEXOR SHUTTLE SELECT GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY TO TARGET THE RIGHT POPLITEAL ARTERY. THE ANATOMY WAS REPORTEDLY NOT TORTUOUS, SCARRED, OR CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE SHEATH, AND RESISTANCE ENCOUNTERED UPON SHEATH REMOVAL WAS REPORTEDLY ¿NOT ANY MORE THAN USUAL.¿ AN UNSPECIFIED WIRE GUIDE WAS USED DURING THE PROCEDURE, AS WELL AS ANOTHER MANUFACTURER¿S CATHETER, ATHERECTOMY DEVICE, AND BALLOON. PER THE REPORTER, THE SHEATH SEPARATED AND UPON ATTEMPTED REMOVAL, IT SEPARATED INTO THREE MORE PIECES. A CUT-DOWN WAS PERFORMED TO REMOVE THE SHEATH FRAGMENTS AND COMPLETE THE PROCEDURE. ANESTHESIA AND FLUOROSCOPY TIME WERE PROLONGED, ADDITIONAL CONTRAST WAS NEEDED, AND THE PATIENT RECEIVED A TOTAL OF THREE UNITS OF PACKED RED BLOOD CELLS. UNSPECIFIED ADVERSE EFFECTS REPORTEDLY OCCURRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH WAS SEPARATED INTO FOUR SEGMENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22376642 ↗
• MalfunctionOct 24, 2023Break; Unraveled Material; Break; Unraveled Material

  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 17999271 ↗
• MalfunctionNov 18, 2021Unraveled Material; Unraveled Material

  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 12834895 ↗
• MalfunctionApr 20, 2021Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11696990 ↗
• InjuryNov 9, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED ON 09NOV2020: THE PATIENT WAS NOTED TO BE RECOVERING WELL WITH NO LASTING ISSUES. THE PATIENT WAS NOTED TO BE A SMOKER BUT DID NOT HAVE SCARRED ANATOMY, NOR TORTUOUS OR CALCIFIED VESSELS. PATIENT WAS HERE FOR COMMON CAROTID STENT FOR SEVERE STENOSIS, HOWEVER, SHEATH DID NOT TRAVERSE STENOSIS. THE EVENT OCCURRED MID-PROCEDURE AND NO DILATOR WAS IN PLACE. THE SEPARATION OCCURRED WHILE WORKING THE DEVICE THROUGH THE SHEATH. THE SHEATH WAS REMOVED WITHOUT THE DILATOR BECAUSE A BROKEN WIRE WAS TRAPPED WITHIN THE SHEATH. THE WIRE BROKE BECAUSE OF THE SHEATH DEFECT AND COULD NOT BE REMOVED SEPARATELY FOR FEAR OF DISLODGING IN THE BRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10810705 ↗
• MalfunctionFeb 7, 2020Unraveled Material; Unraveled Material

  AS REPORTED, DURING PLACEMENT OF AN UNKNOWN STENT INVOLVING THE CAROTID ARTERY, A FLEXOR SHUTTLE SELECT GUIDING SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. AS THE USER ATTEMPTED TO EXCHANGE THE SHEATH FOR AN ALTERNATE APPROACH, IT UNRAVELED AT THE END AS IT WAS PULLED OUT. AN UNKNOWN WIRE GUIDE WAS UTILIZED DURING THE PROCEDURE. DETAILS OF THE PATIENT'S ANATOMY ARE UNKNOWN. IT IS UNKNOWN IF THE DILATOR OR ANY OTHER DEVICE WAS IN THE LUMEN OF THE SHEATH AT THE TIME OF THE EVENT. RESISTANCE WAS NOT REPORTED DURING INSERTION OR REMOVAL OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SHEATH AND THE PATIENT WAS REPORTEDLY STABLE. 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 9680977 ↗
• MalfunctionJan 20, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9606793 ↗
• MalfunctionSep 6, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 8969727 ↗
• MalfunctionJul 30, 2019Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842285 ↗
• MalfunctionMay 1, 2019Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570085 ↗
• MalfunctionDec 4, 2018Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT PRIOR TO A PERIPHERAL ANGIOGRAM, A FLEXOR SHUTTLE SELECT GUIDING SHEATH SEPARATED. WHEN REMOVING THE DEVICE FROM THE PACKAGE, THE SHEATH SEPARATED FROM THE HUB AND THE COIL UNRAVELED. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED USING ANOTHER FLEXOR SHUTTLE SELECT GUIDING SHEATH. 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 Patient Involvement

  MAUDE report 8129929 ↗
• MalfunctionAug 2, 2018Material Separation; Material Separation

  IT WAS REPORTED, PRIOR TO A DIAGNOSTIC ANGIOGRAPHY PROCEDURE, THE FLEXOR SHUTTLE SELECT GUIDING SHEATH WAS FOUND TO HAVE A BROKEN HUB UPON REMOVAL FROM THE PACKAGE. THE DEVICE WAS FLUSHED WITH SALINE BUT NEVER MADE CONTACT WITH THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO PATIENT ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7744247 ↗
• MalfunctionApr 23, 2018Difficult to Insert; Split; Difficult to Insert; Split

  IT WAS REPORTED THAT THE FLEXOR SHUTTLE SELECT GUIDING SHEATH DID NOT INSERT SMOOTHLY INTO THE PATIENT'S SKIN DURING AN UNSPECIFIED SUPERFICIAL FEMORAL ARTERY PROCEDURE. THE ACCESS SITE WAS DESCRIBED AS NORMAL TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE. ACCORDING TO THE INITIAL REPORTER, 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450364 ↗
• MalfunctionDec 27, 2017Break; Break

  IT WAS REPORTED THAT DURING A CAROTID INTERVENTION, THE FLEXOR SHUTTLE SELECT GUIDING SHEATH BROKE. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7149575 ↗
• MalfunctionJul 12, 2017Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A NEUROANGIOGRAPHY WITH INTERVENTION WITH A FLEXOR SHUTTLE SELECT GUIDING SHEATH IT WAS NOTED THAT THE END OF THE SHEATH DID NOT HAVE THE RADIOPAQUE MARKER. THE PHYSICIAN VERIFIED IT WAS THE ONLY DEVICE THAT WAS MISSING THE MARKER. NO OTHER SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE HAVE BEEN NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708000 ↗
• MalfunctionJun 23, 2017Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A CAROTIS STENTING PROCEDURE USING A FLEXOR SHUTTLE SELECT GUIDING SHEATH, THE RADIOPAQUE MARKER ON THE TIP WAS NOT VISIBLE. BUT THE PHYSICIAN WAS ABLE TO FINISH THE PROCEDURE WITH THIS INTRODUCER. 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 Known Impact Or Consequence To Patient

  MAUDE report 6665323 ↗
• MalfunctionJun 13, 2017Split; Wrinkled; Split; Wrinkled

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR CAROTID ARTERY INTERVENTION VIA FEMORAL ARTERY ACCESS, THE END OF THE FLEXOR SHUTTLE SELECT GUIDING SHEATH WAS NOTED TO BE BLUNT AND UNSHAPELY ON THE TRANSITION BETWEEN THE SHEATH AND THE DILATOR. THERE WAS NO REPORTED INJURY TO THE PATIENT. DURING EVALUATION OF THE DEVICE BY THE MANUFACTURER THE TIP OF THE SHEATH WAS NOTED TO BE WRINKLED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6639037 ↗
• MalfunctionMay 26, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID STENTING, ACCESS TRANSFEMORAL RIGHT SIDE PROCEDURE USING A FLEXOR SHUTTLE SELECT GUIDING SHEATH, THE PHYSICIAN REPORTED THAT THE FLEXOR AT THE HUB WAS VERY FLEXIBLE AND UNSTABLE. IT DID NOT APPEAR TO BE SEALED ALLOWING BLOOD TO FLOW OUT. IT WAS REPORTED THAT THE FLEXOR GOT SEPARATED FROM THE REST OF THE PRODUCT. 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 Known Impact Or Consequence To Patient

  MAUDE report 6593540 ↗
• MalfunctionMay 18, 2017Break; Device Operates Differently Than Expected

  DURING PROCEDURE IT WAS NOTED THAT THE END OF THE SHEATH WAS BLUNT AND UNSHAPELY-ON THE TRANSITION BETWEEN SHEATH AND DILATOR. THE PHYSICIAN WAS NOT ABLE TO INTRODUCE THE SHEATH BECAUSE OF DAMAGING OF THE TIP. SO THEY HAD TO USE ANOTHER ONE TO CONTINUE THIS PROCEDURE. NO PROBLEMS WITH THIS PATIENT AFTER THAT AND NORMAL OUTCOME OF THIS INTERVENTION. 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. PER FURTHER REVIEW IT WAS NOTED THE TIP DAMAGE HAD KEEN EDGES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6576780 ↗
• DeathFeb 9, 2017Split; Difficult to Advance; Split; Difficult to Advance

  INITIAL INFORMATION STATED THAT ADVANCEMENT DIFFICULTY WAS EXPERIENCED DURING THE PROCEDURE OF RECANALISATION OF A.CAROTIS INTERNA AND A CEREBRI MEDIA. AT THIS TIME, IT WAS NOTED THE INTRODUCER WAS CRACKED. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT PLACEMENT OF THE COOK SHUTTLE SHEATH IN LEFT COMMON CAROTID ARTERY VIA TERUMO STIFF WIRE(.035) VIA ANOTHER MANUFACTURER'S 5F/ 130 CM CATHETER. DURING THE INTERVENTION, IT WAS NOTED THAT, FOLLOWING THE STENTING OF THE CAROTID ARTERY, THE SHEATH COULD NOT BE GUIDED FURTHER IN THE DISTAL DIRECTION (NOT AN UNUSUAL OCCURRENCE IN THE CASE OF ELONGATIONS) AND THAT THE DILATATION BALLOON (FOLLOWING THE IMPLANTATION OF THE STENT) SHOWED SIGNS OF INCREASED FRICTION WHILE BEING WITHDRAWN THROUGH THE SHEATH. OTHER MATERIALS (ANOTHER MANUFACTURER'S CATHETER, ETC.) WERE GUIDED THROUGH THE SHEATH WITHOUT PROBLEMS. THERE WAS NO DISLOCATION OF THE SHEATH INTO THE AORTIC ARCH THROUGH KICKBACK AT ANY TIME. NO FORCED MANIPULATIONS. IT WAS ADVISED THAT THE SHEATH DAMAGE WAS DISCOVERED FOLLOWING COMPLETION OF THE INTERVENTION AND REMOVAL OF THE SHEATH FROM THE PATIENT WHEN CHANGING TO A SHORT SIZE 7F SHEATH (IN ORDER TO USE THE EXOSEAL CLOSING SYSTEM).

  Patient problems: Death

  MAUDE report 6314111 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A FLEXOR SHUTTLE SELECT GUIDING SHEATH. THE ATTENDING PHYSICIAN INDICATED THAT THE ENTIRE VALVE BROKE OFF FROM THE SHEATH ONCE THE DEVICE WAS INITIALLY REMOVED FROM THE PRODUCT PACKAGING AND LAID ON THE TABLE. THE DEVICE MALFUNCTION OCCURRED PRIOR TO PATIENT USE. THE DEVICE WAS REPLACED AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6291720 ↗
• InjuryDec 9, 2016Material Separation; Material Separation

  IT WAS REPORTED AT THE COMPLETION OF THE PROCEDURE THE PHYSICIAN WAS REMOVING THE SHEATH THAT WAS PLACED IN THE LEG THROUGH THE FEMORAL ACCESS AND IT 'SEPARATED" AND PEELED AWAY WITH ABOUT 6" LEFT IN THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE ALL THE PARTS BY USING A SNAP TO "GRAB ENOUGH OF IT FROM THE ACCESS SITE TO SAFELY REMOVE IT WITHOUT CAUSING ANY BODILY HARM." THE PATIENTS ANATOMY REPORTEDLY "DID NOT APPEAR TORTUOUS OR CALCIFIED." 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 Known Impact Or Consequence To Patient

  MAUDE report 6159330 ↗