HydroPICC PICC-142SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00862559000425), received between Dec 6, 2021 and Dec 6, 2021 — classified as 2 injuries.

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. 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.

• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "ACUTE DEEP VENOUS THROMBOSIS (DVT) IS NOTED INVOLVING THE RIGHT AXILLARY VEIN(S). ACUTE DEEP VENOUS THROMBOSIS (DVT) IS NOTED INVOLVING THE RIGHT AXILLARY VEIN(S). THROMBUS WAS ASSOCIATED WITH A PICC LINE. ACUTE SUPERFICIAL VENOUS THROMBOSIS (SVT) IS SEEN INVOLVING THE RIGHT BASILIC VEIN OF THE UPPER ARM. THROMBUS WAS ASSOCIATED WITH A PICC LINE." IT WAS ALSO REPORTED THAT ON (B)(6) 2021: "NO CHANGE IN PATIENT CONDITION."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12934252 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PATIENT'S THIRD VISIT: "PATIENT HAD THE FOLLOWING: LEFT BRACHIAL VEINS-ACUTE THROMBUS, PICC LINE: PARTIAL COMPRESSION:NORMAL PHASIC FLOW. LEFT ULNAR VEINS: ACUTE THROMBUS, PICC LINE: NO COMPRESSION LEFT BASILIC VEINS: UPPER ARM, ACUTE THROMBUS, PICC LINE, NO COMPRESSION LEFT CEPHALIC VEIN: UPPER ARM, ACUTE THROMBUS: NO COMPRESSION LEFT CEPHALIC VEIN: FOREARM: ACUTE THROMBUS: NO COMPRESSION [THE PHYSICIAN] WAS NOTIFIED THE SAME DAY AS EVENT. [THE PHYSICIAN] VERIFIED RESULTS. PATIENT WAS PLACED ON ANTICOAGULATION BY ATTENDING. PATIENT IS ASYMPTOMATIC."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12933663 ↗

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