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ARROW IPN920814Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen PICC · Class 2 · Implant

All models of ARROW (1494)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20801902198079), received between Apr 17, 2023 and Apr 17, 2023 — classified as 1 injury.

11 other recalls cover devices cleared under the same FDA submission (K112896); 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Perforation of Vessels1
  • Pleural Effusion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE COMPLAINT IS REPORTED AS: PICC WAS INSERTED ON TUESDAY (B)(6) 2023 IN THE OPERATING THEATRE FOR POST-OP TPN. PICC WAS NOT TRIMMED. THE LINE WAS PLACED BY ANAESTHETIC REGISTRAR, DIRECTLY SUPERVISED BY ANAESTHETIC CONSULTANT UNDER ULTRASOUND GUIDANCE ON THE FIRST PASS WITH NO PROBLEMS USING A MODIFIED SELDINGER TECHNIQUE. IT WAS REPORTED ONE LUMEN WAS BLEEDING BACK AND FLUSHING FINE AND THE OTHER ONE WASN'T BLEEDING BACK. THE CATHETER WAS SECURED WITH STATLOCK, 17CM EXPOSED. THE LOCATION WAS CONFIRMED BY CHEST X-RAY AND LINE RELEASED TO BE USED. PATIENT RECEIVED PARENTERAL NUTRITION VIA PICC AT 20ML/HR, INCREASED TO 50ML/HR AND FINALLY 70ML/HR. ON THURSDAY, (B)(6) 2023, PATIENT WAS FOUND TO BE IN RESPIRATORY DISTRESS AND ADMITTED TO ICU. CTPA WAS ORDERED TO RULE OUT PULMONARY EMBOLUS (PE). THERE WAS NO PE BUT CT SHOWED BILATERAL PLEURAL EFFUSIONS WHICH WERE DRAINED ON FRIDAY (B)(6) 2023. PLEURAL EFFUSIONS WERE MILKY WHITE IN COLOR. RADIOLOGIST WAS RE-CONSULTED. CT IMAGES WERE RELOOKED AT AND THEN FOUND THAT THE TIP PERFORATED THE LEFT BRACHO-CEPHALIC VEIN. TIP WAS LYING 3 CM OUTSIDE THE LEFT BRACHIOCEPHALIC VEIN. CLINICAL CONSEQUENCES: PATIENT BECAME CRITICALLY ILL, REQUIRED ICU

    Patient problems: Perforation of Vessels; Pleural Effusion

    MAUDE report 16752032 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112896. 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-1819-2019 · Apr 23, 2019 · Terminated
    Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL
  • Z-1822-2019 · Apr 23, 2019 · Terminated
    Arrow PICC with Chlorag+ard Technology Product Code:PR 45552 HPHNM
  • Z-1820-2019 · Apr 23, 2019 · Terminated
    Arrow PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
  • Z-1811-2019 · Apr 23, 2019 · Terminated
    Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
  • Z-1327-2018 · Dec 22, 2017 · Terminated
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
  • Z-0996-2018 · Nov 27, 2017 · Terminated
    Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow CVC is indicated to provide short-ter
  • Z-2698-2017 · Jun 12, 2017 · Terminated
    Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
  • Z-2331-2017 · May 9, 2017 · Terminated
    1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for
  • Z-1705-2017 · Mar 3, 2017 · Terminated
    The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
  • Z-0207-2016 · Oct 16, 2015 · Terminated
    ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS

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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