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ARROW IPN056332Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen PICC Kit pre-loaded with Arrow(R) VPS Precision(TM) Stylet · Class 2 · Implant

All models of ARROW (1494)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902161724), received between May 25, 2021 and Jun 12, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K122545); 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 18, 2026.

Most reported problems

Device problems

  • Physical Resistance/Sticking5
  • Deformation Due to Compressive Stress1
  • Difficult to Remove1
  • Output Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 12, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT: WHILE ATTEMPTING TO INSERT A DOUBLE LUMEN PICC UTILIZING A GUIDEWIRE , WITH A LEFT SIDED APPROACH IN A CEPHALIC VEIN, THERE WERE NO ISSUES WITH CATHETER PLACEMENT AND THE BLUE BULLSEYE INDICATOR CONFIRMED PLACEMENT. HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE. THE DOPPLER WIRE REMOVED EASILY. AFTER A FEW MORE ATTEMPTS AT REMOVING THE GUIDEWIRE THEY NOTICED THAT THE CATHETER WAS BUNCHING UP (LIKE AN ACCORDION) WHERE THE 0CM MARK MEETS THE BLUE HUB. THEY WERE UNABLE TO REMOVE THE GUIDEWIRE AND HAD TO ABORT THE PICC PLACEMENT. ALL WIRES WERE REMOVED AND INTACT. THEY HAD TO SWITCH SIDES. WITH THE CATHETER OUT, THEY NOTICED THAT THERE WAS A PORTION OF THE CATHETER THAT WAS "OUT OF ROUND." WITH SOME MANIPULATION OF THE CATHETER AT THESE SPOTS THE WIRE DID COME FREE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17107648 ↗
  • MalfunctionApr 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    CUSTOMER NOTICED THE PICC WAS TIGHT GOING THROUGH THE PEEL AWAY SHEATH INTRODUCER AND HAD TO REMOVE THE PEEL AWAY SHEATH INTRODUCER MUCH EARLIER THAN THEY WANTED TO IN ORDER TO GET THE PICC TO INSERT ALL THE WAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14046297 ↗
  • MalfunctionApr 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    CUSTOMER NOTICED THE PICC WAS TIGHT GOING THROUGH THE PEEL AWAY SHEATH INTRODUCER AND HAD TO REMOVE THE PEEL AWAY SHEATH INTRODUCER MUCH EARLIER THAN THEY WANTED TO IN ORDER TO GET THE PICC TO INSERT ALL THE WAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14046293 ↗
  • MalfunctionApr 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    CUSTOMER NOTICED THE PICC WAS TIGHT GOING THROUGH THE PEEL AWAY SHEATH INTRODUCER AND HAD TO REMOVE THE PEEL AWAY SHEATH INTRODUCER MUCH EARLIER THAN THEY WANTED TO IN ORDER TO GET THE PICC TO INSERT ALL THE WAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14046213 ↗
  • MalfunctionApr 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    CUSTOMER NOTICED THE PICC WAS TIGHT GOING THROUGH THE PEEL AWAY SHEATH INTRODUCER AND HAD TO REMOVE THE PEEL AWAY SHEATH INTRODUCER MUCH EARLIER THAN THEY WANTED TO IN ORDER TO GET THE PICC TO INSERT ALL THE WAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14046164 ↗
  • MalfunctionApr 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    CUSTOMER NOTICED THE PICC WAS TIGHT GOING THROUGH THE PEEL AWAY SHEATH INTRODUCER AND HAD TO REMOVE THE PEEL AWAY SHEATH INTRODUCER MUCH EARLIER THAN THEY WANTED TO IN ORDER TO GET THE PICC TO INSERT ALL THE WAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14046111 ↗
  • MalfunctionMay 25, 2021Output Problem; Output Problem

    CUSTOMER REPORTED G4 HAD NO SOUND OR SIGNAL SO THEY ENDED UP NEEDING TO OPEN A WHOLE NEW KIT JUST TO GRAB THE STYLET. AFTER REPLACING THE G4 STYLET WITH A NEW ONE THE CASE WENT FINE. NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11876022 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122545. One submission often covers many models, so check the product and lot details in each record.

  • Z-2378-2026 · Apr 21, 2026 · Open, Classified
    Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR
  • Z-1030-2015 · Jan 9, 2015 · Terminated
    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices

All Catheter, intravascular, therapeutic, long-term greater than 30 days devices →

Sources and updates

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