ARROW IPN036838Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902122262), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

9 other recalls cover devices cleared under the same FDA submission (K011761); 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-2369-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. 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 ↗

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.

• InjurySep 27, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT: "WITHIN 3 MINUTES OF PLACEMENT OF MAC CATHETER, PATIENT HAD AN ANAPHYLACTIC SHOCK. AS THE ANAESTHESIA STAFF AND OR TEAM WERE MADE AWARE THAT THE PATIENT HAD A CHLORHEXIDINE ALLERGY THIS MORNING, THEY DID NOT USE ANY SUBSIDIARY CHLORHEXIDINE PRODUCTS (MOUTH SCUBS, SAGE CLOTHS, ETC). HOWEVER, THE PATIENT DID USE CHLORHEXIDINE WIPES AT HOME THE NIGHT BEFORE AND HAD HIVES ON HIS SKIN WHEN HE ARRIVED TO PRE-OP (WHICH IS WHEN THEY BECAME AWARE OF HIS ALLERGY). ANAESTHESIA WAS NOT AWARE THAT THE MAC CATHETER WAS IMPREGNATED WITH CHLORHEXIDINE SILVER-SULFADIAZINE SO IT WAS USED. PATIENT CODED BEFORE THE CHEST WAS CRACKED OPEN AND PATIENT WAS PUT IN A BALLOON PUMP. ADDITIONAL INFORMATION: ANAPHYLACTIC SHOCK TO ASYSTOLE CARDIAC ARREST INTRAOP. PATIENT TREATED WITH PEPSID, BENADRYL, AND STEROID. THE PATIENT WAS STABILIZED AFTER THEY OPENED THE CHEST. TREATMENT AFTER ANAPHYLACTIC REACTION: ACLS, CPR, STEROIDS, IVF, INTUBATION, AND ICU. PATIENT IS EXTUBATED, AWAKE, COMMUNICATIVE, AND ON 2L O2 CURRENTLY. HAS RETURNED TO BASELINE WITH WHEEZING."

  Patient problems: Anaphylactic Shock

  MAUDE report 20320018 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011761. One submission often covers many models, so check the product and lot details in each record.

• Z-2555-2019 · Aug 6, 2019 · Terminated
  8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device wit
• Z-1983-2018 · Apr 11, 2018 · Terminated
  MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product
• Z-1324-2018 · Dec 22, 2017 · Terminated
  (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Centra
• Z-1000-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of disease
• Z-1002-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous
• Z-2333-2017 · May 9, 2017 · Terminated
  1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACT
• Z-2825-2015 · Aug 27, 2015 · Terminated
  Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
• Z-0066-2015 · Aug 6, 2014 · Terminated
  Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
• Z-0783-2010 · Nov 24, 2009 · Terminated
  MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with