Snowden-Pencer 89-6110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403122811), received between Mar 7, 2024 and Jun 25, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K092684); 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Break; Break

  THE USER FACILITY REPORTED THAT THEIR DIAMOND-FLEXTRIANGULAR RETRACTOR "BROKE" DURING A PATIENT PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22333463 ↗
• MalfunctionApr 3, 2025Break; Break

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES TWO OF THEIR SNOWDEN-PENCER MIS DIAMOND-FLEXTRIANGULAR RETRACTORS "BROKE" RESULTING IN PROCEDURE DELAYS. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766117 ↗
• MalfunctionMay 15, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE INTERNAL WIRE TO THEIR DIAMOND FLEXTRIANGULAR RETRACTOR "BROKE" WHEN THE SURGEON WAS REMOVING THE DEVICE FROM THE LAPAROSCOPIC PORT. AN X-RAY WAS TAKEN OF THE PATIENT AND CONFIRMED NO DEVICE PIECES WERE PRESENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321546 ↗
• MalfunctionMar 7, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THAT THEIR SNOWDEN-PENCER TRIANGULAR RETRACTOR BROKE AND FELL INTO THE PATIENT'S BODY. THE DETACHED COMPONENTS WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857980 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092684. One submission often covers many models, so check the product and lot details in each record.

• Z-2212-2016 · Jul 1, 2016 · Terminated
  DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue