Caprosyn SC-644Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521034976), received between Jan 2, 2018 and Oct 18, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN SUTURING THE SKIN, THE NEEDLE CAME OFF. THE NEEDLE DID NOT FELL IN THE PATIENT CAVITY. A NEW SUTURE WAS BROUGHT UP TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480682 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD SEPARATED FROM THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269187 ↗
• MalfunctionAug 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CAESARIAN SECTION SURGERY, PRIOR TO USE THE DEVICE ON PATIENT, NEEDLE DETACHED FROM THE THREAD. THE SURGERY WAS DELAYED NOT MORE THAN 30 MINUTES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332803 ↗
• MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CHOLECYSTECTOMY, WHEN OPENING THE SUTURE, THE NEEDLE WASN¿T ATTACHED TO THE STRAND. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10714140 ↗
• MalfunctionOct 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BREAKS FROM THE STRAND VERY EASY.

  Patient problems: No Information

  MAUDE report 10643330 ↗
• MalfunctionJul 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE SUTURE ENVELOPE WAS OPENED, THE NEEDLE AND THREAD WERE NOT CONNECTED AND WERE SEPARATED FROM THE BEGINNING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10329377 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE THREAD BROKE. THE CUSTOMER PICKED ANOTHER SUTURE TO COMPLETE THE CASE. NO PATIENT INJURY NOTED ON THIS EVENT. THE PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316606 ↗
• MalfunctionJan 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BREAST REDUCTION PROCEDURE, WHILE ON THE TABLE BEFORE HANDING THE SUTURE TO SURGEON, THE DEVICE¿S SUTURE CAME OUT OF SWAGE/COMING OFF FROM THE SWAGE BEFORE DOING STITCHES. IN ORDER TO RESOLVE THE ISSUE, ANOTHER FOIL OF SUTURE WAS USED WHICH WORKED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7159116 ↗