HydroPICC PICC-142Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00862559000418), received between Jun 10, 2020 and Oct 15, 2020 — classified as 4 malfunctions.

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

1 FDA recall record name this device's identifier.

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. Feb 24, 2021Terminated

   Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

   Z-0199-2023 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, 1 DAY AFTER BEING IMPLANTED, THE HYDROPICC WAS UNABLE TO BE FLUSHED, AND THAT A GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE ENTIRE LENGTH OF THE CATHETER. THE CATHETER WAS EXPLANTED WHERE A KNOT WAS OBSERVED AT THE DISTAL END OF THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 10684564 ↗
• MalfunctionSep 10, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE HYDROPIC CATHETER HAD BEEN SUCCESSFULLY IMPLANTED ON (B)(6) 2020 WITHOUT ANY ISSUES. THEN, NINE DAYS LATER, IT WAS REPORTED THAT THE CATHETER HAD RETRACTED APPROXIMATELY 6 CM OUTSIDE THE PATIENT AND THAT A CRACK IN THE CATHETER BECAME EVIDENT AFTER ATTEMPTING TO FLUSH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10514468 ↗
• MalfunctionJun 11, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CLINICIAN WAS NOTIFIED THAT THE HYDROPICC "WASN'T WORKING, REPOSITIONING THE INFUSION RESULTED IN LEAKING AT SITE." WHEN THE CLINICIAN ARRIVED ON SITE, THEY "SUTURED CUT LINE PULLED BACK AT [SIC] FOUND TO BE KINKED AND CRACKED AT THE SUTURE WING STEM/CATHETER JUNCTION."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10145379 ↗
• MalfunctionJun 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE HYDROPICC WAS PLACED ON (B)(6) 2020 WITHOUT ISSUE. THEN, ON (B)(6) 2020, THE CLINICIAN WAS CONTACTED TO CONSULT ON AN ALLEGED LEAKING CATHETER. ON (B)(6) 2020, THE CLINICIAN COMMUNICATED, BY EMAIL, THAT "...MY UPSTANDING[SIC] IS PT ACCIDENTALLY PULLED ON THE LINE IT WAS FOUND OUT A FEW 3CM SECURED ONLY BY TEGADERM BY THE BEDSIDE NURSE AND WE WERE CONSULTED FOR LEAKING LINE. MY NURSE FOUND THE PROXIMAL END DRIED, KINDER[SIC] AND CRACKED.""UPON STERILE SALINE INSTALLATION.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140052 ↗

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-1130-2023 · Dec 16, 2022 · Open, Classified
  HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
• Z-1131-2023 · Dec 16, 2022 · Open, Classified
  HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001