ARROW IPN920060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902192643), received between Apr 11, 2023 and Sep 29, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K113277); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933190 ↗
• MalfunctionSep 6, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50638652 ↗
• MalfunctionJun 9, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), ORIGINALLY PLACED ON (B)(6) 2026, BECAME OCCLUDED ON (B)(6) 2026. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. THE ONLY INTERVENTION REQUIRED WAS REMOVAL OF THE AFFECTED DEVICE AND REPLACEMENT WITH ANOTHER PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444661 ↗
• MalfunctionJun 9, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), ORIGINALLY PLACED ON (B)(6) 2026, BECAME OCCLUDED ON (B)(6) 2026. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. THE ONLY INTERVENTION REQUIRED WAS REMOVAL OF THE AFFECTED DEVICE AND REPLACEMENT WITH ANOTHER PICC. THE REPORTER ADDITIONALLY NOTED A TREND AT THE SITE, INDICATING AN INCREASED NUMBER OF PICC OCCLUSIONS DESPITE ADHERENCE TO ROUTINE CARE AND MAINTENANCE PRACTICES. NO SPECIFIC PATIENT INJURY OR ADVERSE OUTCOMES WERE REPORTED IN ASSOCIATION WITH THESE ADDITIONAL EVENTS; MANAGEMENT FOR THOSE CASES SIMILARLY INVOLVED DEVICE REMOVAL AND REPLACEMENT. ASSOCIATED MDRS INCLUDE 9680794-2026-00446 (MULTIPLE EVENTS WITHOUT ADDITIONAL PATIENT-SPECIFIC DETAILS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444458 ↗
• MalfunctionApr 16, 2026Crack

  IT WAS REPORTED "PICC LINE INSERTED- PATIENT WENT FOR A CONTRACT INJECTION, INFILTRATION OF CONTRAST AT PICC INSERTION SITE- PICC RE MOVED-LOOKED LIKE THERE WAS A CRACK IN THE PICC LINE AT CM 40CM, 5ML/PER SEC INJECTION OMIPICC 350 INJECTION." THE PICC LINE WAS EXCHANGED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24903322 ↗
• MalfunctionApr 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  PHYSICIAN FOUND THE GUIDEWIRE KINKED AND BENT DURING USE. IT WAS REPORTED THERE WAS RESISTANCE WITH THE NEEDLE AND THE WIRE WAS FRAYED UPON REMOVAL. A SECOND INSERTION WITH A NEW CATHETER KIT WAS SUCCESSFUL. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113277. 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-1254-2020 · Dec 20, 2019 · Terminated
  PICC Set- PR-35052-HPHNM
• Z-2023-2018 · Apr 11, 2018 · Terminated
  ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
• Z-0602-2018 · Jul 25, 2017 · Terminated
  ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
• Z-0182-2018 · Jun 1, 2017 · Terminated
  ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central
• 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