ARROW IPN033150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902094763), received between Jun 2, 2024 and Jun 2, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

11 other recalls cover devices cleared under the same FDA submission (K061289); 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

Recent adverse event reports

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

• MalfunctionJun 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "AT THE TIME OF OPENING THE KIT, THE GUIDE WIRE WAS BENT". THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444883 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061289. One submission often covers many models, so check the product and lot details in each record.

• Z-1255-2020 · Dec 20, 2019 · Terminated
  Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
• Z-2020-2018 · Apr 11, 2018 · Terminated
  PICC Catheter Trimmer ; Product Code:PC-00001-T
• Z-1325-2018 · Dec 22, 2017 · Terminated
  Arrow Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
• Z-2338-2017 · May 9, 2017 · Terminated
  Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term p
• Z-2771-2016 · Feb 17, 2016 · Terminated
  Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
• Z-2772-2016 · Feb 17, 2016 · Terminated
  Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
• Z-2774-2016 · Feb 17, 2016 · Terminated
  Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or c
• Z-2773-2016 · Feb 17, 2016 · Terminated
  Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
• Z-0127-2016 · Sep 18, 2015 · Terminated
  4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
• Z-1682-2010 · Mar 29, 2010 · Terminated
  Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-0704