HydroPICC Basic Kit (70cm GW) 80H01102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850030354297), received between Jul 1, 2026 and Aug 26, 2026 — classified as 1 injury, 1 malfunction.

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

4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryAug 26, 2026Insufficient Device Problem Information

  Patient problems: Medical device site infection

  MAUDE report 50463038 ↗
• MalfunctionJul 1, 2026Fracture

  COMPANY CONTACTED CUSTOMER OF A SINGLE LUMEN PICC "RUPTURE". NO OTHER INFORAMTION WAS MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25682236 ↗

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-1130-2023 · Dec 16, 2022 · Open, Classified
  HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
• Z-0199-2023 · Feb 24, 2021 · Terminated
  Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter