ARROW IPN033136Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801902100535), received between Jul 12, 2023 and Jan 12, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Missing Information” (3 reports).

11 other recalls cover devices cleared under the same FDA submission (K820009); 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6)2025, (B)(6) IN DEPARTMENT OF ANESTHESIOLOGY THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 24037197 ↗
• MalfunctionJul 28, 2025Migration; Migration

  IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND THE SUTURE WING DAMAGED DURING USE ON THE PATIENT. AND THEN THE CATHETER REMOVE IT. SINCE THE PATIENTS WERE 1 AND 4 YEARS OLD, HOW MUCH FORCE WAS REQUIRED TO RIP THE SUTURE WINGS OFF." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 22628949 ↗
• MalfunctionJan 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR FOUND SWG KINKED DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103835 ↗
• MalfunctionNov 21, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT "WHILE CHECKING THE CATHETER (PRIOR TO USE ON A PATIENT) UNDER STERILE CONDITIONS, IT WAS OBSERVED THAT THE WIRE DID NOT PASS THROUGH THE NEEDLE AND GETS STUCK." THE OPERATOR CHANGED TO A NEW KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747009 ↗
• MalfunctionAug 6, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT " DEVICE WITHOUT CENTIMETRE MARKINGS ON CATHETERS. CUSTOMER NOTICED THIS ON ALL CATHETERS FROM STOCK. PRIOR TO USE." ASSOCIATED COMPLAINTS: 9680794-2024-00759, 9680794-2024-00760, 9680794-2024-00761, 9680794-2024-00762, 9680794-2024-00763 AND 9680794-2024-00764.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19915425 ↗
• MalfunctionAug 5, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT " DEVICE WITHOUT CENTIMETRE MARKINGS ON CATHETERS. CUSTOMER NOTICED THIS ON ALL CATHETERS FROM STOCK. PRIOR TO USE." ASSOCIATED COMPLAINTS: 9680794-2024-00759, 9680794-2024-00760, 9680794-2024-00761, 9680794-2024-00762, 9680794-2024-00763 AND 9680794-2024-00764.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19904062 ↗
• MalfunctionAug 5, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT " DEVICE WITHOUT CENTIMETRE MARKINGS ON CATHETERS. CUSTOMER NOTICED THIS ON ALL CATHETERS FROM STOCK. PRIOR TO USE." ASSOCIATED COMPLAINTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19904051 ↗
• InjuryApr 23, 2024Material Separation; Material Separation

  IT WAS REPORTED " IN ORDER TO PREP FOR AN EMERGENCY SURGERY, AN A-LINE INSERTION WAS PLANNED. THE MD STARTED A RIGHT FEMORAL A-LINE INSERTION. DURING THE PROCEDURE THE MD FOUND THE GUIDE WIRE TO BE FAULTY AND STOPPED THE PROCEDURE. IN ATTEMPTS TO REMOVE THE GUIDE WIRE, A PART OF THE WIRE BECAME LOOSE. THROUGH ULTRASOUND, THE MD IDENTIFIED THE REMAINING GUIDE WIRE WITHIN THE INSERTION AREA. THE MD DECIDED IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AT AN OR AND REMOVED THE GUIDE WIRE THAT WAS OUTSIDE OF THE PATIENT'S BODY AND DRESSED THE WOUND. AFTER EXPLAINING THE SITUATION TO THE PATIENT, THE MD REMOVED THE PART OF THE GUIDE WIRE REMAINING WITHIN THE BODY." AN ULTRASOUND WAS USED TO CONFIRM REMAINING PIECES WITHIN THE PATIENT. SURGICAL REMOVAL WAS REQUIRED AND A FOLLOW UP CT SCAN WAS COMPLETED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN" AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 19164487 ↗
• MalfunctionFeb 9, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE GUIDE WIRE TO BE FAULTY. SO THE MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE RETURNED DEVICE WAS NOTED TO BE SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675866 ↗
• MalfunctionJul 12, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ENTER THE GUIDEWIRE INTO THE RAULERSON SYRINGE. A NEW KIT WAS OPENED TO FINISH THE PROCEDURE. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17310969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K820009. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1243-2020 · Dec 20, 2019 · Terminated
  Arrow Central Venous Catheterization Kit ASK-04200-UPM
• Z-1974-2018 · Apr 11, 2018 · Terminated
  Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
• Z-1331-2018 · Dec 22, 2017 · Terminated
  (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) V
• Z-2328-2017 · May 9, 2017 · Terminated
  Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulati
• Z-1347-2011 · Oct 29, 2010 · Terminated
  VESSEL CATHETERIZATION KIT/Product SKU's (Codes) AK-04550, AK-4550-A and ASK-04550-TG. Vessel catheterization kit
• Z-1349-2011 · Oct 29, 2010 · Terminated
  JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800. Jugular puncture kit
• Z-1344-2011 · Oct 29, 2010 · Terminated
  INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050 Internal jugular puncture kit
• Z-1345-2011 · Oct 29, 2010 · Terminated
  PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture kit
• Z-1348-2011 · Oct 29, 2010 · Terminated
  CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660. Central venous catheterization kit
• Z-1494-2009 · Feb 11, 2009 · Terminated
  Arrow Single Lumen CVCs (Central Venous Catheters)