Concerto Detachable Coil System NV-6-20-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00847536044951), received between Aug 18, 2022 and Feb 24, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION RECEIVED. THE VESSEL WAS EITHER THE RIMA OR LIMA. SIZE OR TORTUOSITY WERE NOT KNOWN. PROCEDURE WAS COMPLETED WITH ANOTHER COIL. NO KNOW CAUSES FOR PREMATURE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433512 ↗
• InjuryFeb 16, 2026Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS DETACHED USING THE DETACHER. IT WAS STATED THAT THE PATIENT HAD PRESENTED WITH ABDOMINAL PAIN AND THE AREA COILED WAS AN INCIDENTAL FINDING THAT COULD HAVE BEEN THE CAUSE AND SO THE COILING PROCEDURE WAS DONE. THE PATIENT RETURNED WITH ABDOMINAL PAIN, BUT THE DOCTOR DID NOT KNOW IF IT WAS THE SAME PAIN OR DIFFERENT. THE ABDOMINAL CT FOUND THE FILAMENT EXTENDING FROM THE INITIAL COIL THROUGH THE OTHER COILS INTO THE AORTA AND DOWN INTO THE EXTERNAL ILIAC AREA. IT IS NOT KNOWN IF ANTICOAGULANTS WERE ADMINISTERED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24352782 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137111 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ATTEMPTED DEPLOYMENT OF THE COIL CONCERTO HELIX 6MM X 20CM, THE STRING BROKE AND THE COIL COULD NOT BE DEPLOYED. THE COIL TRACKED THROUGH THE MICRO CATHETER AND COILED AS INTENDED, BUT WHEN DEPLOYMENT WAS ATTEMPTED, THE STRING BROKE, PREVENTING SUCCESSFUL DEPLOYMENT. THE WIRE AND COIL WERE SUBSEQUENTLY REMOVED WITHOUT ISSUE. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924547 ↗
• MalfunctionDec 4, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A GDA BLEED. THE VESSEL SIZE WAS APPROXIMATELY 4-5 MM. THEY USED OTHER CONCERTO COILS TO PACK THE BLEED AND COMPLETE THE PROCEDURE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WERE NO ISSUES PRIOR TO THE COIL NON-DETACHMENT. NO DAMAGE WAS NOTED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718709 ↗
• MalfunctionJun 24, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THE COIL (WITH LOT#228640128) HAD RESISTANCE IN THE SHEATH. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322801 ↗
• MalfunctionJun 24, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COILS (LOT: 229646653 AND 229927355) COULD NOT BE DETACHED BY DETACHER, AND PHYSICIAN REFUSED TO USE BACK UP DEPLOYMENT. THERE WAS NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. COIL (LOT: 228640128) COULD NOT BE DETACHED BY DETACHER, AND PHYSICIAN BROKE THE HYPOTUBE, THE COIL DID NOT SEPARATE INSTANTLY, WHILE RETRIEVING THE COIL FROM PATIENT, THE COIL SUDDENLY DEPOLYED, AND GOT STUCK IN MICROCATHETER (LOT: B615929). THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES AND 1 TIME USING THE MANUAL METHOD. TWO INSTANT DETACHERS WERE USED. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER TWICE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. COIL (LOT: B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322797 ↗
• MalfunctionMay 16, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS BEING USED AS PER THE IFU BUT THE COIL WAS KINKED WITHIN THE MICROCATHETER. A NEW MEDTRONIC PRODUCT USED TO COMPLETE THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WERE NO ISSUES WITH THE CATHETER. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040086 ↗
• MalfunctionMar 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, COMPLICATIONS, OR INJURY ASSOCIATED WITH THE CONCERTO PUSHWIRE SEPARATION EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL. THE CAUSE OF THE CONCERTO PUSHWIRE BREAK/SEPARATION WAS UNKNOWN. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE COIL WAS DETACHED BEFORE DETACHMENT ATTEMPTS. THE COIL WAS REMOVED FROM THE PATIENT. THE COIL PUSHWIRE BROKE IN THE CATHETER DURING DELIVERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619945 ↗
• MalfunctionJan 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE INVOLVING THE USE OF A COIL CONCERTO HELIX 6MM X 20CM, THE COIL BECAME STUCK IN THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE CATHETER WAS NOT A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160370 ↗
• MalfunctionJul 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DEPLOYED UPON REMOVING IT FROM THE STORAGE TUBE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791029 ↗
• MalfunctionJun 27, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT TWO 5 X 15 CONCERTO COILS OF THE SAME MODEL AND LOT HAD RESISTANCE/WERE STUCK AT THE NON-MEDTRONIC CATHETER HUB. A REPLACEMENT COIL WAS USED TO CONTINUE THE PROCEDURE. DURING THE SAME PROCEDURE, TWO 6 X 20 CONCERTO COILS OF THE SAME MODEL BUT DIFFERENT LOTS COULD NOT BE DETACHED. THE INSTANT DETACHER WAS REPLACED AND OTHER COILS WERE USED AND DETACHED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICE: PROGREAT MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625005 ↗
• MalfunctionJun 27, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT TWO 5 X 15 CONCERTO COILS OF THE SAME MODEL AND LOT HAD RESISTANCE/WERE STUCK AT THE NON-MEDTRONIC CATHETER HUB. A REPLACEMENT COIL WAS USED TO CONTINUE THE PROCEDURE. DURING THE SAME PROCEDURE, TWO 6 X 20 CONCERTO COILS OF THE SAME MODEL BUT DIFFERENT LOTS COULD NOT BE DETACHED. THE INSTANT DETACHER WAS REPLACED AND OTHER COILS WERE USED AND DETACHED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICE: PROGREAT MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624810 ↗
• MalfunctionJun 13, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ENDOLEAK. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT PRIOR COILS PLACED AND DETACHED IN ENDOLEAK WITH NO ISSUE. UPON TRYING TO DETACH THE LAST 6X20 COIL BY BREAKING BETWEEN THE TWO BLACK MARKS, IT WOULD NOT DETACH. WE TRIED TO DETACH FURTHER DOWN THE WIRE WITH NO RESULT. PULLED OUT WITHOUT COMPLICATION AND ANOTHER COIL WAS USED AND DETACHED WITHOUT COMPLICATION. THE PHYSICIAN DID NOT ATTEMPT TO DETACH WITH AN INSTANT DETACHER. THERE WERE 4 MANUAL DETACHMENT ATTEMPTS. THERE WAS NO ISSUE WITH THE INSTANT DETACHMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A TERUMO PROGREAT MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529237 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WAS NOT ATTACHED TO THE PUSHER OUT OF BOX. WHEN THE HEALTHCARE PROVIDER OPENED THE PACKAGE THE CONCERTO COIL DROPPED ON THE FLOOR. IT WAS NOTED THAT IT SOUNDED LIKE THE COIL WAS NOT ATTACHED TO THE PUSHER. A HANDLING ISSUE WAS NOT SUSPECTED. THE LESION/VESSEL SITE OR LOCATION ASSOCIATED WITH THE EVENT. THE LOCATION WITHIN ARTERY(S), TYPE OF TARGET LESION, DEGREE OF TORTUOSITY, DEGREE OF CALCIFICATION AND % LESION STENOSIS WAS UNKNOWN. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS UNKNOWN IF THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354165 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD 6 CONCERTO COILS IMPLANTED TO TREAT A 13MM SACCULAR ANEURYSM WITH VESSEL OCCLUSION COIL EMBOLIZATION ON (B)(6) 2022. ALL THE INVOLVED COILS WERE DELIVERED AND DEPLOYED SUCCESSFULLY TO ACHIEVE SUCCESSFUL TREATMENT OF THE TARGET VESSEL. NO DEVICE MALFUNCTION WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED ISCHEMIC CHOLECYSTITIS. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE EVENT RESOLVED WITH THE MEDICAL TREATMENT AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THE SITE AND STUDY SPONSOR ASSESSMENTS OF THE EVENT BOTH CONCLUDED THE EVENT WAS POSSIBLY/PROBABLY RELATED TO THE INDEX PROCEDURE BUT NOT RELATED TO THE CONCERTO DEVICES.

  Patient problems: Inflammation; Ischemia

  MAUDE report 19128970 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD 6 CONCERTO COILS IMPLANTED TO TREAT A 13MM SACCULAR ANEURYSM WITH VESSEL OCCLUSION COIL EMBOLIZATION ON (B)(6) 2022. ALL THE INVOLVED COILS WERE DELIVERED AND DEPLOYED SUCCESSFULLY TO ACHIEVE SUCCESSFUL TREATMENT OF THE TARGET VESSEL. NO DEVICE MALFUNCTION WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED ISCHEMIC CHOLECYSTITIS. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE EVENT RESOLVED WITH THE MEDICAL TREATMENT AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THE SITE AND STUDY SPONSOR ASSESSMENTS OF THE EVENT BOTH CONCLUDED THE EVENT WAS POSSIBLY/PROBABLY RELATED TO THE INDEX PROCEDURE BUT NOT RELATED TO THE CONCERTO DEVICES.

  Patient problems: Inflammation; Ischemia

  MAUDE report 19128875 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS LOOSE INSIDE THE MICROCATHETER AND COULD NOT BE PUSHED. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480787 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS LOOSE INSIDE THE MICROCATHETER AND COULD NOT BE PUSHED. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480759 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DETACHED DURING PRE-OP. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480758 ↗
• MalfunctionJan 2, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS GETTING STUCK TO THE MICROCATHETER TERUMO 2.7FR. THE COIL WAS DAMAGED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  ANCILLARY DEVICES INCLUDE A TERUMO 2.7FR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424741 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT A CONCERTO COIL PREMATURELY DETACHED DURING IMPLANT. IT WAS UNKNOWN IF THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). LESION/VESSEL SITE: LEFT UE FISTULAGRAM/ EMBOLIZATION OF COMPETING FLOW. IN THE LEFT ARTERY/VEIN (LOCATION UNKNOWN) WITH AN UNKNOWN TARGET LESION. THE DEGREE OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE ARTERY DIAMETER AND LESION LENGTH WAS NOT SPECIFIED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE PERCENT LESION STENOSIS WAS UNKNOWN. THE HEALTHCARE PROVIDER NOTICED THE SEPARATION OF THE COIL FROM THE DETACHMENT AREA WHILE IMPLANTING. THE CONCERTO COIL KINKED WHILE PUSHING THE DEVICE FORWARD. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230771 ↗
• MalfunctionNov 7, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULDN'T DEPLOY. THE CONCERTO COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083701 ↗
• MalfunctionSep 14, 2023Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL BEING USED IN A PROCEDURE. IT WAS UNKNOWN IF THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT THE PHYSICIAN BROKE THE PUSHER WIRE MANUALLY BUT ALSO BROKE THE DETACHMENT WIRE AT THAT TIME WHICH WOULD NORMALLY RELEASE THE COIL. THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND DISCARDED IT. ANOTHER COIL WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746220 ↗
• MalfunctionSep 8, 2023Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT THREE CONCERTO COILS OF DIFFERENT MODELS AND LOTS WHICH HAD NOTED HYPOTUBE KINK BEFORE USE IN THE PATIENT. IT WAS NOTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COILS WERE REPLACED TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ANCILLARY DEVICE: REBAR 18 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONCE IT WAS OPENED, IT IS DISCOVERED IT WAS BENT. IT WAS NEVER USED ONCE DISCOVERED THAT IT WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712746 ↗