Caprosyn SC-692Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521035003), received between Aug 17, 2021 and Nov 19, 2025 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 16, 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.

• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, IN THE REMOVAL OF A MASS ON A DOG, THE NEEDLE DETACHED FROM THE SUTURE STRAND WHILE REMOVING THE SUTURE FROM THE RETAINER AND PREPARING IT PRIOR TO PATIENT INCISION. THE ISSUE OCCURRED WITH TWO STRANDS FROM THE SAME PRODUCT AND LOT. A RAPID SUTURE FROM ANOTHER MANUFACTURER WAS USED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597984 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, IN THE REMOVAL OF A MASS ON A DOG, THE NEEDLE DETACHED FROM THE SUTURE STRAND WHILE REMOVING THE SUTURE FROM THE RETAINER AND PREPARING IT PRIOR TO PATIENT INCISION. THE ISSUE OCCURRED WITH TWO STRANDS FROM THE SAME PRODUCT AND LOT. A RAPID SUTURE FROM ANOTHER MANUFACTURER WAS USED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597942 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, TWO NEEDLES BROKE WHILE REMOVING THE NEEDLED SUTURE FROM THE PACKAGING, AND THE NEEDLE DID NOT FALL IN THE PATIENT CAVITY.

  Patient problems: Insufficient Information

  MAUDE report 23595100 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, TWO NEEDLES BROKE WHILE REMOVING THE NEEDLED SUTURE FROM THE PACKAGING, AND THE NEEDLE DID NOT FALL IN THE PATIENT CAVITY.

  Patient problems: Insufficient Information

  MAUDE report 23595078 ↗
• MalfunctionOct 20, 2025Break; Break

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF NORMAL DELIVERY, AFTER 4-5 DAYS THE PATIENT CALLED THE HOSPITAL AND COMPLAINED THAT THE SUTURE STRAND HAD BROKEN. ANOTHER SUTURE FROM DIFFERENT LOT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23335446 ↗
• InjuryOct 19, 2025Break; Break

  IT WAS REPORTED THAT POSTOPERATIVELY OF NORMAL DELIVERY, A COUPLE OF DAYS AFTER SUTURING, THE SUTURE BROKE IN THE MIDDLE OF THE STRAND. THE PATIENT CALLED AND WAS READMITTED TO THE HOSPITAL. THE WOUND REQUIRED RESUTURING, AND A NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23334111 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WAS ABOUT TO START THE FIRST STITCH, WITH THE NEEDLE IN THE NEEDLE DRIVER, THE NEEDLE CAME OFF THE FIRST THREAD. THE SECOND THREAD BROKE WHEN THE OPERATING ROOM NURSE STRAIGHTENED THE THREAD BEFORE HANDING IT OVER TO THE SURGEON. ON THE THIRD THREAD, THE STAFF TRIED TO BEND THE THREAD, AND IT BROKE RIGHT AWAY, IT WAS BRITTLE, AND IT WAS LIKE BREAKING SPAGHETTI. THE THREAD DID NOT BREAK WHEN THE USER WAS TAKING THE DEVICE OUT OF THE PACKAGE. THE SURGEON AND THE NURSE SAW WHAT HAPPENED AND REMOVED THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201751 ↗
• MalfunctionJun 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE; WHILE REMOVING FROM THE RETAINER / PREPARING THE SUTURE PRIOR TO PATIENT INCISION, THE NEEDLES CAME LOOSE FROM THE THREAD AND THE THREAD ALSO BROKE VERY EASILY. THESE ISSUES WERE NOTED WITH MULTIPLE DEVICES FROM THE SAME BOX.

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

  MAUDE report 22127639 ↗
• MalfunctionJun 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE REMOVING FROM THE RETAINER / PREPARING THE SUTURE PRIOR TO PATIENT INCISION, THE NEEDLES CAME LOOSE FROM THE THREAD AND THE THREAD ALSO BROKE VERY EASILY. THESE ISSUES WERE NOTED WITH MULTIPLE DEVICES FROM THE SAME BOX.

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

  MAUDE report 22127527 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING SUTURES, THE NEEDLE BROKE WHILE SUTURING. THE BROKEN DEVICE WAS FOUND IN THE PATIENT'S SCAR, AND THE SURGEON SUCCESSFULLY RECOVERED THE ENTIRE DEVICE. A NEW SUTURE OF THE SAME REFERENCE WAS USED WITHOUT ISSUE, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873482 ↗
• MalfunctionDec 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE REMOVING THE SUTURE FROM THE PACKAGING, THE NEEDLE BROKE. WHEN THE DEVICE WAS BEING USED, THE THREAD BROKE EASILY AND THE NEEDLE CAME LOOSE. THE NEEDLE DETACHED. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035507 ↗
• MalfunctionDec 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING THE SKIN CLOSURE OF THE TROCAR INCISIONS, THERE WAS A SUTURE APPEARANCE ISSUE WITH THE DEVICE DURING THE SAME EVENT INVOLVING FOUR DEFECTIVE SUTURES WITH THE SAME PATIENT. IT WAS NOTED THAT THE WHOLE STRAND STARTED TO ABSORB ALREADY. THE ISSUES WERE ASSOCIATED WITH TWO DIFFERENT LOT NUMBERS. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028541 ↗
• MalfunctionDec 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING THE SKIN CLOSURE OF THE TROCAR INCISIONS, THERE WAS A SUTURE APPEARANCE ISSUE WITH THE DEVICE DURING THE SAME EVENT INVOLVING FOUR DEFECTIVE SUTURES WITH THE SAME PATIENT. IT WAS NOTED THAT THE WHOLE STRAND STARTED TO ABSORB ALREADY. THE ISSUES WERE ASSOCIATED WITH TWO DIFFERENT LOT NUMBERS. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028537 ↗
• MalfunctionDec 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING THE SKIN CLOSURE OF THE TROCAR INCISIONS, THERE WAS A SUTURE APPEARANCE ISSUE WITH THE DEVICE DURING THE SAME EVENT INVOLVING FOUR DEFECTIVE SUTURES WITH THE SAME PATIENT. IT WAS NOTED THAT THE WHOLE STRAND STARTED TO ABSORB ALREADY. THE ISSUES WERE ASSOCIATED WITH TWO DIFFERENT LOT NUMBERS. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028536 ↗
• MalfunctionDec 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING THE SKIN CLOSURE OF THE TROCAR INCISIONS, THERE WAS A SUTURE APPEARANCE ISSUE WITH THE DEVICE DURING THE SAME EVENT INVOLVING FOUR DEFECTIVE SUTURES WITH THE SAME PATIENT. IT WAS NOTED THAT THE WHOLE STRAND STARTED TO ABSORB ALREADY. THE ISSUES WERE ASSOCIATED WITH TWO DIFFERENT LOT NUMBERS. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028534 ↗
• MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 20673757 ↗
• MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE DETACHED WHILE REMOVING FROM THE RETAINER. THE NEEDLE WAS LOOSE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20671039 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED. THE SAME ISSUE OCCURRED WITH THE OTHER THREE SUTURES. THE ISSUE WAS DETECTED WHEN THE SUTURES WERE REMOVED FROM THE CONTAINER AND/OR WHEN SUTURING BEGAN. A FIFTH SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246574 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED. THE SAME ISSUE OCCURRED WITH THE OTHER THREE SUTURES. THE ISSUE WAS DETECTED WHEN THE SUTURES WERE REMOVED FROM THE CONTAINER AND/OR WHEN SUTURING BEGAN. A FIFTH SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246525 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED. THE SAME ISSUE OCCURRED WITH THE OTHER THREE SUTURES. THE ISSUE WAS DETECTED WHEN THE SUTURES WERE REMOVED FROM THE CONTAINER AND/OR WHEN SUTURING BEGAN. A FIFTH SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246483 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED. THE SAME ISSUE OCCURRED WITH THE OTHER THREE SUTURES. THE ISSUE WAS DETECTED WHEN THE SUTURES WERE REMOVED FROM THE CONTAINER AND/OR WHEN SUTURING BEGAN. A FIFTH SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246291 ↗
• MalfunctionSep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON A FLANK CAT SPAY, USING THE INTRADERMAL SIMPLE INTERRUPTED SUTURING TECHNIQUE FOR TWO LAYER CLOSURE OF MUSCLE WALL WITH CRUCIATE MATTRESS SUTURES, THE CAT WAS DISCHARGED WITH ELIZABETHAN COLLAR. THE CAT PRESENTED AT 10PM WITH BREAKDOWN OF ALL LAYERS AND SUBSEQUENT EVISCERATION. EUTHANASIA WAS PERFORMED.

  Patient problems: Tissue Breakdown

  MAUDE report 15395285 ↗
• MalfunctionSep 7, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SUTURE WAS USED AND THE WOUND SOMEHOW CAME APART. IT WAS NOT RULED OUT THAT THE ANIMAL HAS HAD ACCESS TO THE WOUND, NOR THAT THE WOUND WAS STITCHED CORRECTLY. SUTURE WAS REQUESTED FOR TESTING. CUSTOMER WOULD LIKE SUTURE TESTED.

  Patient problems: Insufficient Information

  MAUDE report 15374634 ↗
• MalfunctionAug 17, 2021Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE BROKE OFF FROM THE THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331512 ↗