FLOWMATE® INJKITRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741067693), received between Dec 29, 2020 and Sep 20, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K903390); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 20, 2022Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE EXPIRATION DATE IN KIT WAS ALLEGEDLY NOT THE SAME FROM DATE ON THE BOX. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453457 ↗
• MalfunctionDec 29, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO RECANALIZATION PROCEDURE, THE KIT AND INDIVIDUAL PACKAGING EXPIRY DATES WERE ALLEGEDLY MISMATCHING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085512 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K903390. One submission often covers many models, so check the product and lot details in each record.

• Z-0745-2019 · Dec 14, 2018 · Terminated
  MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Inje