ARROW IPN033388Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801902100979), received between Oct 10, 2023 and Jan 28, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT "DURING THE PICC PROCEDURE, AFTER INSERTION OF THE GUIDEWIRE, THE GUIDEWIRE UNRAVELED DURING REMOVAL, RESULTING IN BREAKAGE OF THE GUIDEWIRE TIP. BOTH THE BROKEN FRAGMENT AND THE REMAINING WIRE WERE SUCCESSFULLY REMOVED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199096 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT "THE TIP OF THE DILATOR BROKE OFF, IT ALSO BROKE WHILE TEARING OPEN THE PEEL-AWAY SHEATH HALFWAY". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00034.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973335 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT "THE TIP OF THE DILATOR BROKE OFF, IT ALSO BROKE WHILE TEARING OPEN THE PEEL-AWAY SHEATH HALFWAY". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00034 AND 9680794-2026-00035.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973332 ↗
• MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "45CM WIRES HAD DISTINCTIVE KINKS WHERE THE STRAIGHT WIRE MEETS THE SOFT TIP.". THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00646 AND 9680794-2025-00632.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629219 ↗
• MalfunctionFeb 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE PEEL AWAY SHEATH DILATOR BIFURCATION". A NEW SET WAS OPENED TO RESOLVE THE ISSUE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396940 ↗
• MalfunctionAug 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT: "THE PICC RUPTURED DURING A CT WITH CONTRAST INJECTION, THE PICC HAD BEEN ASPIRATING AND FLUSHING WITH NO PROBLEMS PRIOR AND THE FLUSH PRE-CONTRAST INJECTION WAS OK, PICC HAD BEEN INSITU FOR 11DAYS PRIOR TO THE CT. CONTRAST EXTRAVASATION INTO TISSUE IN ARM AND TREATED WITH CONTRAST EXTRAVASATION PROTOCOL, ICE, ELEVATE, CONTINUED MONITORING. PICC NOT REPLACED AS TPN HAD CEASED, THE CT WAS A FOLLOW UP SCAN, CT WAS REPEATED THE NEXT DAY WITH PIVC. SALINE PRE INJECTION VIA INJECTOR WAS OK, CONTRAST INJECTOR SETTING PSI LIMIT WAS 246 PSI AND 2.2MLS/SEC, THE PICC GOT TO 246 PSI AT 1.8MLS/SEC. IT WAS THE DISTAL (PINK LUMEN). THE PATIENT WAS REPORTED AS FINE POST THE INCIDENT.".

  Patient problems: Extravasation

  MAUDE report 20062923 ↗
• MalfunctionMay 20, 2024Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT "DURING OPERATING PROCESS, THE PEEL-AWAY SHEATH WAS BROKEN WHEN TEAR OFF." ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352881 ↗
• MalfunctionOct 10, 2023Material Separation; Material Separation

  IT WAS REPORTED "THE TRANSPARENT CATHETER OF THE PICC PINK CONNECTOR WAS BROKEN". THE CATHETER WAS REMOVED. THE PATIENT'S CONDITION IS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905993 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKED WHEN FLUSHED. THE CATHETER HAD BEEN INSERTED SINCE (B)(6). THE CATHETER WAS REMOVED AND A NEW CATHETER WAS PLACED. IT WAS REPORTED THE PATIENT "IS CURRENTLY IN GOOD CONDITION WITH NO ADVERSE REACTIONS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905694 ↗

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