Caprosyn SC-5780GRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521034921), received between Sep 11, 2017 and Apr 18, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PLASTIC SURGERY INVOLVING THE SUTURE, THERE WERE ISSUES WITH NEEDLE DETACHMENT AND SUTURE BREAKAGE. THE NEEDLE DETACHED WHILE SUTURING AND PREPARING THE SUTURE AFTER THE PATIENT INCISION, AND THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD DURING SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. MULTIPLE DEFECTIVE DEVICES FROM THE SAME PRODUCT ID AND LOT NUMBER WERE INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT. INITIALLY, AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE, BUT THE SAME PROBLEM OCCURRED, LEADING TO THE USE OF ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865708 ↗
• MalfunctionApr 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PLASTIC SURGERY INVOLVING THE SUTURE, THERE WERE ISSUES WITH NEEDLE DETACHMENT AND SUTURE BREAKAGE. THE NEEDLE DETACHED WHILE SUTURING AND PREPARING THE SUTURE AFTER THE PATIENT INCISION, AND THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD DURING SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. MULTIPLE DEFECTIVE DEVICES FROM THE SAME PRODUCT ID AND LOT NUMBER WERE INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT. INITIALLY, AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE, BUT THE SAME PROBLEM OCCURRED, LEADING TO THE USE OF ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865644 ↗
• MalfunctionApr 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PLASTIC SURGERY INVOLVING THE SUTURE, THERE WERE ISSUES WITH NEEDLE DETACHMENT AND SUTURE BREAKAGE. THE NEEDLE DETACHED WHILE SUTURING AND PREPARING THE SUTURE AFTER THE PATIENT INCISION, AND THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD DURING SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. MULTIPLE DEFECTIVE DEVICES FROM THE SAME PRODUCT ID AND LOT NUMBER WERE INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT. INITIALLY, AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE, BUT THE SAME PROBLEM OCCURRED, LEADING TO THE USE OF ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865607 ↗
• MalfunctionApr 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PLASTIC SURGERY INVOLVING THE SUTURE, THERE WERE ISSUES WITH NEEDLE DETACHMENT AND SUTURE BREAKAGE. THE NEEDLE DETACHED WHILE SUTURING AND PREPARING THE SUTURE AFTER THE PATIENT INCISION, AND THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD DURING SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. MULTIPLE DEFECTIVE DEVICES FROM THE SAME PRODUCT ID AND LOT NUMBER WERE INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT. INITIALLY, AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE, BUT THE SAME PROBLEM OCCURRED, LEADING TO THE USE OF ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865461 ↗
• MalfunctionApr 4, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHILE REMOVING THE SUTURE FROM THE RETAINER, THE THREAD WAS BROKEN IN THE MIDDLE. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM A DIFFERENT BOX. A NEW SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774398 ↗
• MalfunctionApr 4, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHILE REMOVING THE SUTURE FROM THE RETAINER, THE THREAD WAS BROKEN IN THE MIDDLE. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM A DIFFERENT BOX. A NEW SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774318 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE THREAD WAS DISCONNECTING FROM THE NEEDLE UPON USE.

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

  MAUDE report 20765421 ↗
• MalfunctionJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BILATERAL BREAST RECONSTRUCTION PROCEDURE, WHEN PASSING THE FIRST STITCH, THE NEEDLE CAME OFF THE THREAD AND NO DEVICE FELL INTO THE PATIENT'S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17231993 ↗
• MalfunctionJan 6, 2023Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CIRCUMCISION PROCEDURE, THE ENVELOPE WAS UNCOVERED TO REMOVE THE SUTURE AT THE TIME OF IMPLANTING IT IN THE PATIENT. IT WAS FOUND THAT NEEDLE WAS LOOSE FROM THE THREAD (DISASSEMBLED). THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16116089 ↗
• MalfunctionOct 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN OPENING THE SUTURE ON AN OPEN ORTHOPEDIC PROCEDURE, THE NEEDLE WAS FOUND LOOSE FROM THE STRAND OF THE SUTURE WHEN THE PACKAGE WAS OPENED. ANOTHER UNIT WAS GIVEN FROM THE SAME BOX AND SAME LOT NUMBER WITH NO ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632874 ↗
• MalfunctionSep 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE EMPLOYING A CONTINUOUS SUTURE DURING SKIN CLOSURE IN A OPEN ORTHOPEDIC PROCEDURE, THE NEEDLE AND THREAD BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413997 ↗
• MalfunctionJul 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, USING THE SUB-CUT SKIN TECHNIQUE, THE THREAD CAME AWAY FROM THE NEEDLE WHILE SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182788 ↗
• MalfunctionJul 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, USING THE SUB-CUT SKIN TECHNIQUE, THE THREAD CAME AWAY FROM THE NEEDLE WHILE SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182509 ↗
• MalfunctionJul 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, USING THE SUB-CUT SKIN TECHNIQUE, THE THREAD CAME AWAY FROM THE NEEDLE WHILE SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182376 ↗
• MalfunctionJul 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, DURING SKIN CLOSURE, THE THREAD CAME AWAY FROM THE NEEDLE WHILE SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164419 ↗
• MalfunctionJul 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, USING THE SUB-CUT SKIN TECHNIQUE, THE THREAD CAME AWAY FROM THE NEEDLE WHILE SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12161001 ↗
• MalfunctionFeb 6, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN EMERGENCY LOWER UTERINE SEGMENT CAESAREAN SECTION PROCEDURE, THE SUTURE THREAD BROKE. THE DEVICE WAS REPLACED WITH ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678051 ↗
• MalfunctionDec 11, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN KNOTTING THE SUTURE DURING AN OPEN FLAP SUTURING IN ORAL CANCER, IT WAS STATED THAT AFTER TAKING ONE KNOTS, THE SUTURE THREAD WAS BROKEN. THE SURGEON USED AN ALTERNATIVE SUTURE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453218 ↗
• MalfunctionOct 6, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LOWER SEGMENT CAESAREAN SECTION PROCEDURE, THE THREAD DISCONNECTED FROM THE SWAGE WHEN SUTURING. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9160313 ↗
• InjuryJun 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CYSTECTOMY PROCEDURE, WHILE TYING FALLOPIAN TUBES, NEEDLE DETACHED FROM THE STRAND AND IT FELL INTO THE CAVITY OF THE PATIENT. X-RAY WAS PERFORMED TO LOCATE THE NEEDLE FROM THE ABDOMEN, THE NEEDLE WAS FOUND ON TOP OF THE DRAPES. OPERATING ROOM TIME GOT PROLONGED FOR ALMOST 2 HOURS EXTRA.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 8669401 ↗
• MalfunctionSep 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ORTHOPEDIC PROCEDURE, THE DEVICE NEEDLE AND THREAD WAS BROKEN, IT PARTED WAYS THROUGH THE SKIN CLOSURE. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6856083 ↗