HydroPICCRecalls & reported problems across all models

We found 2 models of HydroPICC by Access Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2020 and Dec 6, 2021 — classified as 2 injuries, 4 malfunctions.

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

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HydroPICC recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

Most reported HydroPICC problems

HydroPICC models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HydroPICC PICC-142

  Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
  1 recall4 reports
• HydroPICC PICC-142S

  Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
  2 reports

Recent HydroPICC adverse event reports

The 6 most recent reports across all models, 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 ↗
• 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 ↗

Other Access Vascular, Inc. products

• HydroMID Maximal Barrier Kit3 models · 31 reports · 2 recalls
• HydroPICC Dual Lumen3 models · 9 reports · 2 recalls
• HydroPICC Maximal Barrier Kit2 models · 16 reports · 1 recall