HydroPICC Dual Lumen 80002002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850030354044), received between Apr 5, 2023 and Apr 5, 2023 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K213550); 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. Aug 31, 2023Class IIOpen, Classified

   Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.

   Z-0114-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DVT REPORTED FOR PATIENT WITH PICC-251 DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16685340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213550. One submission often covers many models, so check the product and lot details in each record.

• Z-0115-2024 · Aug 31, 2023 · Open, Classified
  HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004