Accu-Chek Coaguchek Softclix 07313462001Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 07613336173046), received between Jul 15, 2021 and Oct 31, 2025 — classified as 1 injury, 45 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (39 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF A RETRACTION ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. THE PATIENT ALLEGED THAT A PROPERLY SEATED LANCET PROTRUDED FROM THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438572 ↗
• MalfunctionAug 15, 2025Ejection Problem; Ejection Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCING DEVICE. IT WAS ALLEGED THAT THE DEVICE DID NOT LANCE THE CUSTOMER'S FINGER. DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THE CUSTOMER HAD NOT PRESSED THE YELLOW RELEASE BUTTON ON THE DEVICE. IT WAS ALLEGED THAT THE LANCET FELL OUT OF THE SOFTCLIX DEVICE WHEN THE CAP WAS REMOVED. THE LANCET WAS PROPERLY SEATED BEFORE IT FELL OUT. IT WAS CONFIRMED THAT THE NEEDLE DID NOT PROTRUDE PAST THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817115 ↗
• MalfunctionJul 29, 2025Retraction Problem; Retraction Problem

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. A NEW LANCET WAS INSERTED INTO THE DEVICE, AND THE NEEDLE PROTRUDED FROM THE END CAP. THE LANCET WAS REINSERTED, AND THE NEEDLE NO LONGER PROTRUDED FROM THE END CAP. WHEN THE LANCET WAS PRIMED, THE LANCET PROTRUDED FROM THE END CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642857 ↗
• MalfunctionMar 18, 2025Retraction Problem; Retraction Problem

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. THE REPORTER STATED THAT A LANCET WAS PROPERLY SEATED IN THE DEVICE, BUT THE NEEDLE PROTRUDED PAST THE END CAP OF THE DEVICE. THE REPORTER NOTED THAT THE LANCET NEEDLE APPEARED LONGER THAN OTHER LANCETS IN THE BOX. THE REPORTER INSERTED A NEW LANCET AND THE NEEDLE DID NOT PROTRUDE PAST THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634929 ↗
• MalfunctionMar 14, 2025Material Fragmentation; Material Fragmentation

  WE RECEIVED AN ALLEGATION THAT A PROPERLY SEATED COAGUCHEK XS SOFTCLIX LANCET PROTRUDES FROM THE CORRECTLY POSITIONED END CAP WHEN THE CORRECT LANCET IS USED ON THE COAGUCHEK XS SOFTCLIX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607766 ↗
• MalfunctionNov 5, 2024Retraction Problem; Retraction Problem

  WE RECEIVED AN ALLEGATION THAT A PROPERLY SEATED COAGUCHEK XS SOFTCLIX LANCET PROTRUDES FROM THE CORRECTLY POSITIONED END CAP WHEN THE CORRECT LANCET IS USED ON THE COAGUCHEK XS SOFTCLIX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609879 ↗
• MalfunctionOct 9, 2024Retraction Problem; Retraction Problem

  IT WAS ALLEGED THAT A LANCET WAS PROTRUDING PAST THE END CAP OF A COAGUCHEK XS SOFTCLIX DEVICE. THE CUSTOMER WAS ACCIDENTALLY STUCK BY A LANCET PROTRUDING PAST THE END CAP OF THE COAGUCHEK XS SOFTCLIX DEVICE. THE CUSTOMER DID NOT REQUIRE TREATMENT. THE CUSTOMER BELIEVED THE LANCET WAS SEATED PROPERLY, BUT COULD NOT CONFIRM THIS AS THE LANCET HAD ALREADY BEEN REPLACED. THE CUSTOMER WAS ADVISED ON HOW TO PRIME AND FIRE THE DEVICE. THE LANCET NO LONGER PROTRUDED PAST THE END CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409495 ↗
• MalfunctionMar 25, 2024Retraction Problem; Retraction Problem

  THE CUSTOMER STATED THERE WAS AN ISSUE WITH THE COAGUCHEK SOFTCLIX LANCING DEVICE. THE CUSTOMER INDICATED THAT THE LANCET WAS PROTRUDING PAST THE END CAP OF THE LANCING DEVICE BEFORE PRIMING. THE CUSTOMER REMOVED THE CAP OF THE DEVICE AND CONFIRMED THAT THE LANCET WAS SEATED PROPERLY. THE CUSTOMER RE-INSTALLED THE CAP, BUT THE ISSUE PERSISTED. THE LANCET WAS STILL PROTRUDING PAST THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969090 ↗
• MalfunctionMar 11, 2024Retraction Problem; Retraction Problem

  THE CUSTOMER REPORTED AN ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE CUSTOMER STATED THAT THE NEEDLE WAS PROTRUDING OUT OF THE SOFTCLIX LANCET DEVICE AFTER POKING THEIR FINGER. THE CUSTOMER NOTED THAT THE LANCET WAS PROTRUDING PAST THE CAP OF THE DEVICE PRIOR TO THE CUSTOMER POKING THEIR FINGER AS WELL. THE CUSTOMER CONFIRMED THAT THE LANCET WAS SEATED PROPERLY IN THE DEVICE. THE CUSTOMER CONFIRMED THEY WERE NOT HARMED DUE TO POKING THEIR FINGER WITH THE PROTRUDING LANCET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875084 ↗
• MalfunctionOct 11, 2023Retraction Problem; Retraction Problem

  IT WAS ALLEGED THAT A USER HAD AN ISSUE WITH A COAGUCHEK SOFTCLIX DEVICE. THE USER ALLEGED THAT THE NEEDLE WAS STICKING OUT FROM THE DIAL CAP OF THE SOFTCLIX DEVICE BEFORE FIRING THE LANCET. THE USER VERIFIED THAT THE DIAL CAP WAS ON PROPERLY. THE USER DID NOT ALLEGE ANY INJURIES OR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913522 ↗
• MalfunctionOct 11, 2023Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH THE COAGUCHEK XS SOFTCLIX. THE CUSTOMER ALLEGED THE LANCET WAS PROTRUDING FROM THE DIAL END CAP BEFORE FIRING AND IT WILL NOT WORK. THE LANCET WAS SEATED PROPERLY AND THE DIAL CAP WAS ON CORRECTLY. THERE WAS NO ACCIDENTAL STICK DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913354 ↗
• MalfunctionAug 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE WAS AN ALLEGATION OF A COAGUCHEK XS SOFTCLIX LANCET THAT WAS NOT WORKING PROPERLY. THE CUSTOMER STATED THAT THE LANCET WAS BARELY ABLE TO PUNCTURE THEIR FINGER AND THAT THE LANCET NEEDLE IS EXTENDING PAST THE CAP. THE CUSTOMER STATED THAT THEY WERE ABLE TO SEAT THE LANCET IN PLACE AND SET THE DEPTH SETTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484141 ↗
• MalfunctionJul 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE WAS AN ALLEGATION OF A RETRACTION ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. ON TROUBLESHOOTING, THE REPORTER NOTICED THAT THE LANCET WAS STICKING OUT PAST THE END CAP OF THE SOFTCLIX DEVICE AFTER PRIMING. THE REPORTER STATED THAT THE LANCET WAS SEATED PROPERLY AT THE TIME THE LANCET WOULD NOT RETRACT AND THAT THE DEVICE WAS NOT FIRED BECAUSE THE LANCET WAS ALREADY STICKING OUT. THE REPORTER STATED THAT THE LANCET WAS NOT USED AND NO ONE WAS ACCIDENTALLY STUCK. THE REPORTER INSERTED A NEW LANCET AND WAS ABLE TO PRIME AND FIRE THE DEVICE WITHOUT THE LANCET PROTRUDING. THE REPORTER WAS ABLE TO PERFORM A TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337446 ↗
• MalfunctionJun 27, 2023Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF A RETRACTION ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE REPORTER HAD DIFFICULTY APPLYING THE END CAP TO THE DEVICE. THE LANCET WAS SEATED PROPERLY. THE REPORTER APPLIED THE CAP SECURELY. THE DEVICE WAS PRIMED AND FIRED. THE REPORTER ALLEGED THE LANCET WAS PROTRUDING PAST THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213370 ↗
• MalfunctionApr 28, 2023Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE CUSTOMER ALLEGED THE LANCET WAS PROTRUDING FROM THE END CAP OF THE DEVICE. THE CORRECT LANCETS WERE BEING USED. THE LANCET WAS PROPERLY SEATED IN THE CARRIER. THE CUSTOMER STATED THE MIDDLE PART OF THE DEVICE IS LOOSE AND IT WON'T STAY UP AGAINST THE PLUNGER AT THE END OF THE DEVICE. THE CUSTOMER IS UNABLE TO PRIME OR FIRE THE DEVICE. NO ACCIDENTAL STICK OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835206 ↗
• MalfunctionApr 20, 2023Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF AN ACCIDENTAL NEEDLE STICK FROM A COAGUCHEK SOFTCLIX LANCET DEVICE. THE PATIENT REPORTED THAT THEY HAD ISSUES ADJUSTING THE DEPTH SETTING OF THE LANCET AND THAT THERE HAD BEEN AN INCIDENT WHERE THEY HAD ACCIDENTALLY STUCK THEIR FINGER ON AN EXPOSED LANCET NEEDLE PROTRUDING FROM THE CAP. THE PATIENT STATED THAT THEY DID NOT RECEIVE ANY MEDICAL TREATMENT AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777411 ↗
• MalfunctionApr 12, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE CUSTOMER REPORTED THAT THE CAP WOULD NOT GO ONTO THE DEVICE. THE DEVICE AND THE LANCET WITHIN THE DEVICE WERE REPORTED TO BE SEATED IN THE CORRECT POSITION. WHEN ATTEMPTING TO ATTACH THE CAP TO THE DEVICE, THE CAP REPORTEDLY WOULD NOT ON THE DEVICE. THE LANCET WAS PROTRUDING FROM THE END CAP PRIOR TO FIRING THE LANCET WITH THE DEVICE. NO ACCIDENTAL FINGERSTICKS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726416 ↗
• MalfunctionMar 24, 2023Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH THE COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE CUSTOMER ALLEGED THE LANCET WAS PROTRUDING FROM THE END CAP AFTER FIRING THE DEVICE. THE DIAL CAP WAS PROPERLY SEATED AT THE TIME. THE LANCETS LOT NUMBER WAS 10521052 WITH AN EXPIRATION DATE OF 31-NOV-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610617 ↗
• MalfunctionMar 13, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COAGUCHEK XS SOFCLIX LANCING DEVICE. THE CUSTOMER NOTED THAT THE LANCING DEVICE WILL NO LONGER STICK THEIR FINGER AND THE LANCET WOULD NOT RETRACT. THE DEVICE WILL PRIME AND FIRE THE LANCET. THE LANCET NEEDLE WILL STICK OUT OF THE END CAP AFTER FIRING. THE END CAP WAS CORRECTLY INSTALLED. THERE WAS NO ALLEGATION OF AN ACCIDENTAL FINGERSTICK DUE TO THE EXPOSED NEEDLE. THE CUSTOMER REMOVED THE UNUSED NEEDLE AND MANUALLY STUCK THEIR FINGER TO GET A SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528542 ↗
• MalfunctionFeb 23, 2023Retraction Problem; Retraction Problem

  WE RECEIVED AN ALLEGATION OF A LANCET PROTRUDING FROM THE ENDCAP OF A COAGUCHEK XS SOFTCLIX LANCET DEVICE. IT HAD BEEN REPORTED THAT THE LANCET WAS SET UP CORRECTLY BUT IT PROTRUDED MORE THAN ONCE. DURING THE CALL, THE PATIENT MENTIONED THAT THE NEEDLE WAS NOT CURRENTLY PROTRUDED. NO ACCIDENTAL FINGER STICK OCCURED. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430025 ↗
• MalfunctionJan 25, 2023Retraction Problem; Retraction Problem

  IT WAS ALLEGED THAT THERE WAS AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCING DEVICE. THE CUSTOMER ADVISED THAT THE DEVICE POKES TOO DEEP OR IT DOES NOT POKE DEEP ENOUGH. THE CAP OF THE DEVICE ALSO FALLS OFF AND HAS BEEN FALLING OFF FOR A WHILE. THE LANCET DOES NOT RETRACT WHEN IT POKES TOO DEEP. THE CUSTOMER STATED THE SOFTCLIX DEVICE WAS SET TO "5.5". THE LANCET WAS SEATED PROPERLY IN THE DEVICE WHEN NOT RETRACTED. THE LANCET DID NOT PROTRUDE PAST THE END OF THE CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241676 ↗
• MalfunctionJan 6, 2023Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. THE PATIENT ALLEGED THE LANCET WAS STICKING OUT OF THE END CAP OF THE DEVICE. THE PATIENT STATED THE LANCET WAS "IN THE DEVICE ALL THE WAY." WHEN THE CAP WAS PLACED ON THE DEVICE, THE LANCET STUCK OUT OF THE END CAP. THE PATIENT ACCIDENTALLY STUCK THEIR FINGER WITH THE LANCET; THE PATIENT WAS NOT HARMED DUE TO THE ACCIDENTAL STICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113398 ↗
• InjuryDec 29, 2022Material Fragmentation; Material Fragmentation

  WE RECEIVED AN ALLEGATION THAT THE COAGUCHEK XS SOFTCLIX LANCING DEVICE MAY HAVE CONTRIBUTED TO A BACTERIAL INFECTION OF THE PATIENT'S RING FINGER. THE PATIENT'S WIFE INITIALLY CALLED DUE TO A PERSISTENT ERROR 5 FROM THE COAGUCHEK XS METER. ERROR 5 IS RELATED TO AN ISSUE APPLYING BLOOD TO THE TEST STRIP. THE CALL AGENT REVIEWED WHAT CAUSES ERROR 5. THE PATIENT'S WIFE STATED THE CHANNEL ON THE TEST STRIP WAS NOT GETTING COMPLETELY FILLED WITH BLOOD. THE PATIENT WAS NOT READY TO TEST AGAIN AT THE TIME OF THE CALL. DURING THE CALL, THE PATIENT'S WIFE MENTIONED THAT THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE RING FINGER (THE SPECIFIC PART WAS NOT PROVIDED) HE HAD USED TO PUNCTURE FOR TESTING. THE PATIENT REPORTEDLY GOT AN INFECTION ON HIS RING FINGER AFTER HE PUNCTURED IT AND USED IT FOR TESTING. THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH A BACTERIAL INFECTION. THE PATIENT REPORTEDLY RECEIVED ANTIBIOTIC TREATMENT FOR THE INFECTION. THE PATIENT'S WIFE CONFIRMED THERE WAS NO LANCET PROTRUDING OUT AND THAT THERE WAS NO LANCET BROKEN IN THE FINGER. THE PATIENT'S WIFE STATED THAT THE PATIENT FELT LIKE SOMETHING WAS STUCK IN THE FINGER. AN X-RAY AND COMPUT

  Patient problems: Skin Infection

  MAUDE report 16072337 ↗
• MalfunctionDec 22, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCING DEVICE. THE USER WAS ABLE TO EJECT A LANCET USED FOR A PREVIOUS TEST. WHEN THE USER PUT IN A NEW LANCET, THE EXPOSED NEEDLE WAS STICKING OUT OF THE END CAP OF THE DEVICE. THE USER CONFIRMED THE NEEDLE WAS PROPERLY SEATED IN THE LANCING DEVICE AND THE END CAP WAS PROPERLY SEATED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036840 ↗
• MalfunctionDec 19, 2022Retraction Problem; Retraction Problem

  WE RECEIVED AN ALLEGATION OF AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. THE CUSTOMER ALLEGED THE LANCET SOMETIMES LOOKS CROOKED WHEN IT IS INSERTED INTO THE DEVICE AND SOMETIMES STICKS OUT OF THE END CAP AND SOMETIMES DOES NOT. NO ACCIDENTAL FINGER STICK OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003591 ↗