Caprosyn CC-801Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521034143), received between Jun 2, 2021 and May 24, 2022 — 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.

• MalfunctionMay 24, 2022Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING THE FAT LAYER, THE SUTURE SNAPPED AT SEVERAL POINTS. THE DEVICE KEPT ON SNAPPING AT DIFFERENT POINTS WHILE TYING THE KNOTS. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY BUT NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489533 ↗
• MalfunctionApr 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE THREAD CAME OFF THE NEEDLE AT THE FIRST PULL THROUGH THE FAT TISSUE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164727 ↗
• MalfunctionApr 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE THREAD CAME OFF THE NEEDLE AT THE FIRST PULL THROUGH THE FAT TISSUE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164717 ↗
• MalfunctionApr 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE THREAD CAME OFF THE NEEDLE AT THE FIRST PULL THROUGH THE FAT TISSUE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112122 ↗
• MalfunctionMar 1, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  RECEIVED MULTIPLE REPORTS OF SUTURES DETACHING FROM NEEDLE EITHER WHEN REMOVING FROM PACKET OR MID USE. USUALLY USED FOR FAT LAYER IN C/S, AND USED BY REGISTRARS AND CONSULTANTS. THE REPORTS OF FAULTS HAVE BEEN OVER LAST MONTH. THE PREVIOUS PRODUCT COMPLAINT REPORT WAS SUBMITTED. OTHER BATCHES PRESENT IN THEATRE WITH NO ALTERNATIVE BATCHES AVAILABLE. THE CURRENT BATCH WAS REPORTED BY CONSULTANT. THERE WAS A POTENTIAL TO INJURE THE STAFF IF SUTURE DISCONNECTS MID USE. THE BOX WAS REMOVED FROM THEATRE AS BATCH ISSUE. BOXES WITH SAME BATCH NUMBER PRESENT IN THEATRE AS NO DIFFERENT BATCH AVAILABLE. WHEN SUTURES BREAK MID USE, THE SURGEONS NEED TO OPEN MORE SUTURES AND THIS DELAYS THE PROCEDURES COMPLETION. THERE WAS NO ADVERSE OUTCOME FOR PATIENTS INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633447 ↗
• MalfunctionFeb 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON OPENING THE SUTURE, IT WAS FOUND OUT THAT THE NEEDLE WAS DETACHED FROM THE THREAD. THREE ADDITIONAL SUTURES OPENED HAD THE SAME ISSUE. A NEW BOX OF SUTURE WAS OPENED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13585082 ↗
• MalfunctionFeb 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE THE DEVICE WAS NOT CONNECTED TO THE NEEDLE. THERE WAS A FAULTY ON THE PACKAGING THAT INCLUDES THE BATCH/LOT NUMBER. TO RESOLVE THE ISSUE, THE USER OPENED ANOTHER PACKET WAS OPENED FROM A DIFFERENT BATCH NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509788 ↗
• MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE THREAD OF THE SUTURE DETACHED FROM THE END OF THE NEEDLE. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11923033 ↗