ARROW IPN036449Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

63 other recalls cover devices cleared under the same FDA submission (K002507); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2385-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002507. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2023 · Oct 27, 2022 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
• Z-0352-2023 · Oct 27, 2022 · Terminated
  Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-
• Z-1323-2018 · Dec 22, 2017 · Terminated
  (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow MAC" Two- Lumen Central Venous Access Kit, Product Number:
• Z-2335-2017 · May 9, 2017 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central ci
• Z-2293-2017 · Mar 20, 2017 · Terminated
  Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and cat
• Z-2264-2017 · Mar 20, 2017 · Terminated
  ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the
• Z-2297-2017 · Mar 20, 2017 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vess
• Z-2279-2017 · Mar 20, 2017 · Terminated
  AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or su
• Z-2277-2017 · Mar 20, 2017 · Terminated
  Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimi
• Z-2257-2017 · Mar 20, 2017 · Terminated
  Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days
• Z-2288-2017 · Mar 20, 2017 · Terminated
  Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduct
• Z-2287-2017 · Mar 20, 2017 · Terminated
  Arrow Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used
• Z-2261-2017 · Mar 20, 2017 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr
• Z-2254-2017 · Mar 20, 2017 · Terminated
  ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permi
• Z-2298-2017 · Mar 20, 2017 · Terminated
  QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

…and 48 more.