ZipSeal 24 Surgical Skin Closure Kit PS1243Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853114007232), received between Apr 17, 2019 and Feb 26, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  FOLLOWING COMPLETION OF A TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED SURFACE CLOSURE WITH A ZIPSEAL 24 CONVENIENCE KIT, WHICH CONSISTS OF A ZIPLINE ZIP 24 SURGICAL SKIN CLOSURE DEVICE AND CARDINAL HEALTH LIQUIBAND OCTYL 0.8ML SKIN ADHESIVE. PER THE ZIPLINE TERRITORY MANAGER, THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED A BLISTER UNDER THE ZIP DEVICE. THE SURGEON CHOSE TO RE-ADMIT THE PATIENT AND PERFORM IRRIGATION AND DEBRIDEMENT OF THE BLISTER.

  Patient problems: No Code Available

  MAUDE report 9759446 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOTAL KNEE ARTHROPLASTY PATIENT WAS RE-ADMITTED TO OR FOR RE-CLOSURE OF SURGICAL INCISION FOLLOWING A TRAUMATIC FALL THAT RESULTED IN FAILURE OF DEEP SUTURES AND PARTIAL INCISION DEHISCENCE. SEE VOLUNTARY REPORT NUMBER MW5085079 GENERATED BY USER FACILITY.

  Patient problems: Wound Dehiscence

  MAUDE report 8524232 ↗