PREVELEAK SURGICAL SEALANT ADS201808Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05413765583582), received between Dec 20, 2021 and Jul 23, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (P100030); 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 18, 2026.

Recalls naming this device

1. Dec 6, 2023Class IIOpen, Classified

   Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

   Z-0660-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024

  CT SURGEON REQUESTED TO USE NEW PRODUCT (PREVELEAK) FOR OPEN HEART CASE. VENDOR WAS PRESENT IN THE CASE AND HAD BROUGHT IN A "SAMPLE" OF THE PRODUCT WHICH WAS IN THE SAME BOX THAT THE STERILE PRODUCT WAS PACKAGED IN. BEFORE THE CASE, REGISTERED NURSE (RN) TOOK PRODUCT FROM CORE REFRIGERATOR AND PLACED ON CART IN OR. DURING CASE, SURGEON ASKED FOR THE PRODUCT. VENDOR HAD PLACED THE SAMPLE PRODUCT IN THE SAME AREA AS THE STERILE PRODUCT. WHEN THE SURGEON REQUESTED THE PREVELEAK, SHE TOUCHED ONE OF THE PACKAGES AND SAID "DO NOT OPEN THAT ONE, IT IS MY SAMPLE PRODUCT". RN OPENED THE PRODUCT WHICH VENDOR HAD NOT TOUCHED. AT THE END OF THE CASE VENDOR REALIZED THAT OPENED PRODUCT WAS INDEED THE "SAMPLE" PRODUCT WHICH WAS LABELED AS NON-STERILE, SAMPLE. CURRENT IDENTIFIED ISSUES: 1: THE VENDOR SHOULD NOT BRING IN SAMPLE PRODUCTS INTO THE OR SUITE. 2) THE SAMPLE PRODUCT WAS IN THE SAME PACKAGING AS THE ACTUAL PRODUCT FOR USE WHICH CAUSED CONFUSION. 3) THERE WERE NO PACKAGING DIFFERENCES TO DIFFERENTIATE THE SAMPLE FROM THE STERILE PACKAGE. 4) STICKER WITH "SAMPLE" WARNING WAS ON ONLY ONE SIDE OF THE BOX. PATIENT NOW HAS TO BE FOLLOWED CLOSELY TO PREVENT AND MONITOR FOR ANY SYSTEMIC/CARDIAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805532 ↗
• MalfunctionJun 18, 2024

  THE PREVELEAK SURGICAL SEALANT WAS DEFECTIVE AS PIECES WERE BROKEN IN THE PACKAGE. THIS WAS DISCOVERED AND IT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559225 ↗
• MalfunctionDec 20, 2021Break

  PREVELEAK OPENED TO FIELD DURING OR (OPERATION). WHEN ATTEMPTED TO BE USED BY PHYSICIAN, THE SYRINGE BROKE. PRODUCT WAS NOT ADMINISTERED TO THE SITE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13059539 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100030. One submission often covers many models, so check the product and lot details in each record.

• Z-2687-2017 · Oct 17, 2014 · Terminated
  Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.