HydroPICC Basic Kit (80cm GW) 80001002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00862559000463), received between Oct 14, 2022 and Oct 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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

3 other recalls cover devices cleared under the same FDA submission (K193015); 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.

Recalls naming this device

1. Dec 16, 2022Open, Classified

   Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

   Z-1130-2023 · Root cause: Incorrect or no expiration date · 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.

• MalfunctionOct 14, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HYDROPICC LEAKED. WHEN THE LINE WAS REMOVED, IT WAS NOTED THAT THE CATHETER WAS CRACKED JUST DISTAL TO THE REVERSE TAPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610413 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193015. One submission often covers many models, so check the product and lot details in each record.

• Z-1605-2023 · Mar 3, 2023 · Open, Classified
  HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
• Z-1131-2023 · Dec 16, 2022 · Open, Classified
  HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
• Z-0199-2023 · Feb 24, 2021 · Terminated
  Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter