ARROW IPN921746Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902200447), received between Nov 17, 2021 and Nov 12, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

32 other recalls cover devices cleared under the same FDA submission (K810675); 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-2368-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionNov 12, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT "TUBING DID NOT GIVE ACCURATE BP READING. THEY GRABBED SOME SEPARATE TUBING TO COMPLETE THE PROCEDURE". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532477 ↗
• MalfunctionSep 2, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED "A PA FOR OUR CARDIOTHORACIC SURGERY TEAM JUST PLACED IT. IT BROKE OR SPLICED AS THE PA SAID WHEN SHE ATTEMPTED TO ADVANCE IT. I BELIEVE THIS IS THE SAME ISSUE THAT'S BEEN OCCURRING." ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00728.

  Patient problems: Insufficient Information

  MAUDE report 22932056 ↗
• MalfunctionAug 28, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED "A PA FOR OUR CARDIOTHORACIC SURGERY TEAM JUST PLACED IT. IT BROKE OR SPLICED AS THE PA SAID WHEN SHE ATTEMPTED TO ADVANCE IT. I BELIEVE THIS IS THE SAME ISSUE THAT'S BEEN OCCURRING." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDES: 9680794-2025-00729.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913089 ↗
• MalfunctionJun 5, 2025Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  IT WAS REPORTED "THE CATHETER IS BUCKLING ON INSERTION. THE TIP OF THE 04120 IS BLUNT AND DOESN'T THREAD THROUGH THE SKIN LIKE THE RA-04020." ANOTHER CATHETER WAS USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00467 AND 9680794-2025-00478.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152614 ↗
• MalfunctionSep 18, 2023

  WHILE THE ARTERIAL LINE WAS BEING PLACED, RESISTANCE WAS ENCOUNTERED AS THE GUIDEWIRE WAS INSERTED. THE GUIDEWIRE THEN COULD NOT BE REMOVED. THUS, BOTH THE NEEDLE AND GUIDEWIRE ENDED UP BEING REMOVED AS A UNIT, WHICH LIKELY CONTRIBUTED TO THE HEMATOMA. ONCE OUT OF THE BODY, THE RESIDENT NOTICED THAT THE TIP OF THE GUIDEWIRE APPEARED FRAYED. EVENTUALLY THEY SEPARATED THE GUIDEWIRE AND THE NEEDLE APPARATUS, AT WHICH POINT THE GUIDEWIRE TIP HAD UNRAVELED AND MORE EXTENSIVELY FRAYED. IT WAS DESCRIBED AS HAVING AN APPEARANCE OF A SPIRAL CAT TOY. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, ARROW (PER SITE REPORTER). DEVICE WAS RETURNED TO THE MANUFACTURER.

  Patient problems: Hematoma

  MAUDE report 17763791 ↗
• MalfunctionNov 17, 2021Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THE WIRE WAS UNABLE TO BE REMOVED FROM CATHETER. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830490 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810675. One submission often covers many models, so check the product and lot details in each record.

• Z-2397-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18
• Z-3299-2024 · Jul 26, 2024 · Open, Classified
  Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray
• Z-0844-2020 · Dec 12, 2019 · Open, Classified
  Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04
• Z-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• Z-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• Z-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-1330-2018 · Dec 22, 2017 · Terminated
  (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Fea
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• Z-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220
• Z-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020

…and 17 more.