Zip 8i Surgical Skin Closure Device PS2080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00865379000002), received between Aug 15, 2023 and Jan 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Biocompatibility; Adverse Event Without Identified Device or Use Problem

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 24163999 ↗
• MalfunctionOct 28, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 6 EVENTS FOR THE FAILURE: DIFFICULT TO OPEN OR CLOSE. - 6 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399793 ↗
• MalfunctionJul 29, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: DIFFICULT TO OPEN OR CLOSE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647408 ↗
• MalfunctionJul 24, 2024Biocompatibility; Biocompatibility

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE PATIENT EXPERIENCED A RASH AND ITCHING SYMPTOMS AFTER THE DEVICE WAS USED ON THE SUTURE SITE FOR TREATMENT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Itching Sensation; Rash

  MAUDE report 19823700 ↗
• MalfunctionJul 24, 2024Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823249 ↗
• MalfunctionApr 16, 2024Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. 2 EVENTS HAD AN ADDITIONAL DEVICE REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116082 ↗
• MalfunctionAug 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DEVICE LOCK STRAP DETACHED DURING APPLICATION OF THE ZIP TO A PATIENT. ZIP WAS REPLACED WITH A DIFFERENT ZIP DEVICE. THERE WAS NO PATIENT IMPACT, NO DELAY, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548563 ↗