N/A (REF CTI-512N)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885825013318), received between Nov 29, 2023 and Aug 11, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K053585); they may or may not involve this specific model.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  It was reported the CloseSure Procedure Kit handle broke outside the patient intraoperatively. There was no patient injury reported, and no information was provided regarding medical intervention or extended procedure time. These are commonly used devices that are readily available.

  Patient problems: Insufficient Information

  MAUDE report 50214137 ↗
• MalfunctionJul 14, 2026

  THE CLOSESURE PROCEDURE KIT HANDLE BROKE OUTSIDE THE PATIENT INTRAOPERATIVELY. THIS DEVICE WAS REMOVED AND A NEW KIT WAS USED. NO APPARENT HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25811640 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED DURING THE PROCEDURE THE DEVICE SNAPPED ON THE PLASTIC PART OF THE INSTRUMENT, BUT NOTHING BROKE OFF IN THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24866254 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED DURING THE PROCEDURE THE DEVICE SNAPPED ON THE PLASTIC PART OF THE INSTRUMENT, BUT NOTHING BROKE OFF IN THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24866251 ↗
• MalfunctionMar 23, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT A DEVICE BROKE APART DURING A PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670907 ↗
• MalfunctionMar 23, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT A DEVICE BROKE APART DURING A PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670781 ↗
• MalfunctionMar 23, 2026Break; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THE DEVICE "EXPLODED" INTO SEVERAL PIECES WHEN ON THE STERILE FIELD. IT WAS FURTHER REPORTED THERE WAS NO HARM TO THE PATIENT, BUT THE PART JUST SPRANG ALL OVER THE PLACE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670779 ↗
• MalfunctionMar 12, 2026

  DURING THE PROCEDURE, 2 REPLACEMENT PIECES BY STRYKER WERE USED. THEY BOTH SNAPPED ON THE PLASTIC PART OF THE INSTRUMENT, BUT NOTHING BROKE OFF IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578787 ↗
• MalfunctionMar 10, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT A SUTURE PASSER BROKE DURING USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561000 ↗
• MalfunctionMar 10, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT A SUTURE PASSER BROKE DURING USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560997 ↗
• MalfunctionDec 10, 2025Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  IT WAS REPORTED THAT THE ITEM BROKE ON THE FIELD BEFORE IT WAS USED ON THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771360 ↗
• MalfunctionSep 18, 2025Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  IT WAS REPORTED THAT THE CLOSESURE DEVICE BROKE WHEN INSERTED INTO THE PATIENT. AS REPORTED, NO PIECES FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092007 ↗
• InjuryNov 29, 2023Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  IT WAS REPORTED THE DEVICE HAND PIECE BROKE WHILE IT WAS IN THE PATIENT WHILE THE SURGEON WAS CLOSING THE PORT SITE AND THAT IT WAS TAKEN OUT UNDER DIRECT VISUALIZATION. THERE WAS NO FURTHER DAMAGE REPORTED AND X-RAY WAS USED TO LOCATE AND RETRIEVE ALL PIECES. THERE WAS NO OTHER MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IT NOT AWARE OF THE DURATION OF EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234581 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053585. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2008 · Mar 11, 2008 · Terminated
  Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope and accessories.