DAC 044 90760Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327313918), received between Apr 30, 2018 and May 16, 2018 — classified as 1 injury, 1 malfunction.

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

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

2 other recalls cover devices cleared under the same FDA submission (K133177); 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. Apr 23, 2024Class IIOpen, Classified

   Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

   Z-1908-2024 · Root cause: Process design · Recall details · FDA record ↗

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.

• MalfunctionMay 16, 2018Break; Break

  IT WAS REPORTED THE COIL ENCOUNTERED RESISTANCE DURING INSERTION INTO MICROCATHETER AND BROKE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7519072 ↗
• InjuryApr 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING COIL EMBOLIZATION TREATMENT OF UNRUPTURED A-COM ARTERY (ANTERIOR COMMUNICATION) ANEURYSM, THE STENT (SUBJECT DEVICE) WAS DEPLOYED AND THE NON-STRYKER COIL PLACED PROTRUDED FROM THE STENT AND COULD NOT BE REPOSITIONED. IT WAS REPORTED THE COIL SEPARATED, PROTRUDED INTO THE A-COM ARTERY AND A BLOOD CLOT FORMED INSIDE THE STENT AND SLOWED BLOOD FLOW, REQUIRING MEDICAL INTERVENTION/THROMBOLYSIS. IT WAS FURTHER REPORTED INTUBATION WAS REMOVED 1 WEEK POST-PROCEDURE AND THE PATIENT EXPERIENCED LOWER EXTREMITY PARALYSIS. THE PHYSICIAN CONFIRMED THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE STENT AND STATED THE COIL PROTRUSION AND STENT PLACEMENT IN A SMALL VESSEL (1.8MM) CAUSED THE THROMBOSIS.

  Patient problems: Paralysis; Thrombus

  MAUDE report 7474776 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133177. One submission often covers many models, so check the product and lot details in each record.

• Z-1740-2024 · Apr 3, 2024 · Open, Classified
  The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter s
• Z-0116-2016 · Aug 19, 2015 · Terminated
  Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and g