ARROW IPN037306Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 50801902120781), received between Jan 29, 2021 and Oct 8, 2025 — classified as 6 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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

8 other recalls cover devices cleared under the same FDA submission (K153487); 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-2378-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "PICC LEAKING NEAR WHERE SLIDE CLAMP WAS DISENGAGED PICC REMOVED PER MD OTHER CENTRAL LINE WILL BE ORDERED FOR PATIENT." ANOTHER CATHETER WAS PLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23245251 ↗
• MalfunctionMay 20, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "CUSTOMER REPORTED THAT TIP OF DILATOR FRAYED UPON TRYING TO INSERT. CUSTOMER HAD DROP A SINGLE STERILE DILATOR TO COMPLETE INSERTION." 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 19353096 ↗
• MalfunctionMay 20, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "CUSTOMER REPORTED THAT TIP OF DILATOR FRAYED UPON TRYING TO INSERT. CUSTOMER HAD DROP A SINGLE STERILE DILATOR TO COMPLETE INSERTION." 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 19353094 ↗
• MalfunctionMay 20, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "CUSTOMER REPORTED THAT TIP OF DILATOR FRAYED UPON TRYING TO INSERT. CUSTOMER HAD DROP A SINGLE STERILE DILATOR TO COMPLETE INSERTION." 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 19353068 ↗
• MalfunctionMay 17, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "CUSTOMER REPORTED THAT TIP OF DILATOR FRAYED UPON TRYING TO INSERT. CUSTOMER HAD DROP A SINGLE STERILE DILATOR TO COMPLETE INSERTION." 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 19340473 ↗
• MalfunctionOct 25, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "KINKED PICC WHILE IN-DWELLING". THE CATHETER WAS PLACED ON (B)(6) 2023 IN THE RIGHT BRACHIAL. THE CATHETER WAS NOT FLUSHING AND HAD SLUGGISH OR ABSENT BLOOD RETURN. THE PICC DID NOT HAVE TO BE REMOVED. THE PICC WAS PULLED OUT 2 CM AND XRAY CONFIRMED IT WAS PLACED CENTRAL. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003611 ↗
• InjurySep 11, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED "PATIENT HAD AN AGBA PICC INSERTED AND WITHIN SECONDS HAD AN ANAPHYLACTIC REACTION. PATIENT'S THROAT CLOSED CAUSING AN EMERGENCY. THE PICC CATHETER WAS REMOVED IMMEDIATELY." THE PATIENT REQUIRED ANAPHYLAXIS MEDICATIONS IN LINE WITH ACLS REGIMEN. A NEW VASCULAR ACCESS WAS PLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17718758 ↗
• MalfunctionAug 29, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "WIRE KINKED OUT OF BOX". THERE WAS NO PATIENT INVOLVEMENT WITH THE DEVICE. A NEW KIT WAS OPENED AND A LINE PLACED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646340 ↗
• MalfunctionJun 28, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED "WIRE HAS EXTRA PAINT ON THE PROXIMAL END AND MADE IT SO THE DILATOR COULD NOT BE SUCCESSFULLY THREADED OVER THE WIRE - DEFECT IS VISUALLY AVAILABLE".

  Patient problems: Insufficient Information

  MAUDE report 17216227 ↗
• InjuryMar 27, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  MEDWATCH FORM RECEIVED REPORTS: "PICC LINE INSERTION. CASE PROCEEDED NORMALLY UNTIL LINE WAS IN SUPERIOR VENA CAVA. WHILE POSITIONING THE LAST FEW CM, PATIENT STATED HE WAS FEELING NAUSEOUS. PATIENT FELT THE NEED TO URINATE. PATIENT THEN BEGAN HAVING SEIZURE LIKE MOVEMENTS. PATIENT BECAME UNRESPONSIVE. PROCEDURE ABORTED. CODE BLUE CALLED. DISCOVERED TO BE AN ALLERGIC REACTION TO THE CHLOREHEXIDINE." ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP 25-APR-2023 INDICATES THE PATIENT HAS A COMPLEX MEDICAL HISTORY WITH SEVERAL ALLERGIES. IT WAS ALSO REPORTED THAT THE CODE BLUE WAS CALLED WHEN THE PATIENT'S HEART RATE CHANGED, AND THE PATIENT BECAME UNRESPONSIVE BUT NEVER LOST PULSE. THEY NEEDED TO REMOVE THE CATHETER AND TREAT THE PATIENT WITH LEVOPHED, EPI, BENADRYL AND OXYGEN. SHORTLY AFTER REMOVAL OF THE LINE AND TREATMENT, THE ALLERGY-LIKE SYMPTOMS RESOLVED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR JUST UNDER 24 HOURS FOR OBSERVATION. THERE WAS NO INJURY TO THE PATIENT AND THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS "FINE". THE PATIENT WAS TO FOLLOW UP WITH AN ALLERGIST TO CONFIRM THE CHG ALLERGY; HOWEVER, IT WAS REPORTED THAT THE PATIENT CANCELLED THEIR LAST ALLERGY T

  Patient problems: Convulsion/Seizure; Hypersensitivity/Allergic reaction; Loss of consciousness; Nausea

  MAUDE report 16620205 ↗
• MalfunctionMar 27, 2023Component Misassembled; Component Misassembled

  UPON OPENING THE KIT, THE NURSE FOUND A DOUBLE LUMEN PICC INCLUDED INSTEAD OF A SINGLE LUMEN PICC. ANOTHER KIT HAD TO BE OPENED. NO PATIENT INVOLVEMENT WITH THE DEVICE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620145 ↗
• InjuryMar 7, 2023Use of Device Problem

  PICC LINE INSERTION. CASE PROCEEDED NORMALLY UNTIL LINE WAS IN SUPERIOR VENA CAVA. WHILE POSITIONING THE LAST FEW CM, PATIENT STATED HE WAS FEELING NAUSEOUS. PATIENT FELT THE NEED TO URINATE. PATIENT THEN BEGAN HAVING SEIZURE LIKE MOVEMENTS. PATIENT BECAME UNRESPONSIVE. PROCEDURE ABORTED. CODE BLUE CALLED. DISCOVERED TO BE AN ALLERGIC REACTION TO THE CHLOREHEXIDINE.

  Patient problems: Convulsion/Seizure; Hypersensitivity/Allergic reaction; Nausea

  MAUDE report 16494835 ↗
• MalfunctionSep 15, 2022Break; Break

  CUSTOMER COMPLAINT REPORTS "PEEL AWAY SHEATH HUB CRACKED AND BROKE OFF AS CLINICIAN TRIED TO BREAK AND PEEL AWAY". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428318 ↗
• MalfunctionSep 15, 2022Break; Break

  CUSTOMER COMPLAINT REPORTS "HUB CRACKED OFF ON PEEL AWAY SHEATH AS CLINICIAN TRIED TO BREAK AND PEEL AWAY SHEATH FROM PATIENT". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428317 ↗
• MalfunctionSep 15, 2022Break; Break

  CUSTOMER COMPLAINT REPORTS "HUB CRACKED OFF ON PEEL AWAY SHEATH AS CLINICIAN TRIED TO BREAK AND PEEL AWAY SHEATH FROM PATIENT". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428144 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THE PEEL-AWAY SHEATH WING BROKE OFF WHEN THEY WENT TO PEEL THE SHEATH. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633756 ↗
• InjuryMar 12, 2022Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: PART OF THE PEELAWAY SHEATH BROKE OFF IN THE PATIENT'S SUBCUTANEOUS TISSUE UPON REMOVAL. THE PIECE OF SHEATH HAS REMAINED IN THE PATIENT'S ARM SINCE THE INSERTION ON 28-JANUARY. REMOVAL OF THE SHEATH PIECE WAS TO TAKE PLACE YESTERDAY OR TODAY 18-FEBRUARY BY CUT DOWN OF THE SUBCUTANEOUS TISSUES AT THE INSERTION SITE. THE PIECE WAS NOT ACTUALLY IN THE VESSEL. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13742509 ↗
• MalfunctionMar 1, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED PICC LINE WAS PLACED 19-JAN AND HAD INTERMITTENT ISSUES WITH FLUSHING. TPA (TISSUE PLASMINOGEN ACTIVATOR) WAS GIVEN ON 03-FEB, BUT ON 04-FEB THE NURSE COULD NOT FLUSH THE CATHETER UNTIL HE REPOSITIONED IT AND STRAIGHTENED OUT A "SUBQ KINK". ONCE THE KINK WAS STRAIGHTENED OUT, THE CATHETER FLUSHED WITH EASE. IT WAS ALSO REPORTED THE PICC WAS LEAKING FROM THE LUER HUB/TUBING CONNECTION (CAPTURED IN MDR# 9680794-2022-00118) AND MAY HAVE BEEN SUBJECTED TO A LOT OF PRESSURE BY NURSING STAFF ATTEMPTING TO FLUSH IT. NO PATIENT HARM REPORTED. THE PICC LINE WAS REPLACED WITH A NEW PICC. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638908 ↗
• MalfunctionMar 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED PICC THAT WAS LEAKING FROM THE LUER HUB/TUBING CONNECTION. IT WAS REPORTED THE PICC ALSO HAD INTERMITTENT ISSUES WITH FLUSHING AND "SUBQ KINK" NOTED (CAPTURED IN MDR # 9680794-2022-00164). THE PICC LINE WAS REPLACED WITH A NEW PICC. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638749 ↗
• MalfunctionJan 4, 2022Material Separation; Material Separation

  NURSE REPORTED THE CATHETER WAS FOUND WITH HUB SNAPPED OFF CLEAN. CATHETER WAS THROWN AWAY AND REPLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151638 ↗
• MalfunctionDec 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  WHEN INFUSING, DEVICE IS LEAKING WHERE THE LUMEN MEETS THE PINK LUER LOCK. THE DEVICE WAS REMOVED AND A NEW ONE PLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047119 ↗
• MalfunctionDec 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  WHEN INFUSING, DEVICE IS LEAKING WHERE THE LUMEN MEETS THE PINK LUER LOCK. THE DEVICE WAS REMOVED AND A NEW ONE PLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046972 ↗
• InjuryJul 22, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINT IS REPORTED AS: GETTING READY TO PUT DRESSING ON. BBE (BLUE BULLSEYE) OBTAINED. FLUSHED PICC, AFTER FLUSH PT COMPLAINED OF NAUSEA. RN ATTEMPTED TO FINISH CASE. GOT UNSTERILE/JIGGLED WIRES TO MAKE SURE THE CASE PRINTED. PT BECAME DIAPHORETIC AND VITAL SIGNS WERE ABNORMAL. PICC REMOVED AND CHEST XRAY PERFORMED. TACHYCARDIC, PT COMPLAINED OF BLURRED VISION. PHYSICIAN SUSPECTED AIR EMBOLISM. PT INDICATED THROAT FELT SWOLLEN. IT WAS REPORTED THERE WAS NO AIR EMBOLISM AND CHG (CHLORHEXIDINE) WAS ADDED AS AN ALLERGY FOR THE PATIENT. THE PATIENT WAS TREATED WITH BENADRYL AND STEROIDS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS DOING FINE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12213079 ↗
• InjuryApr 20, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE COMPLAINT IS REPORTED AS: "PICC INSERTION WENT FINE INITIALLY. STYLET MOVED FINE WHEN GOING TO TRIM. IN SVC AND PICC WAS GOING INTO SVC AND AS SOON AS WENT TO CAJ PT STARTED FROTHING AT THE MOUTH, SPITTING, NAUSEA, RIGID, PTS WIFE WAS AT BEDSIDE AND HAD INSERTER REMOVE CATHETER. BLOOD SUGAR WAS 62 AND NOT ABLE TO GET BLOOD PSI. PERFORMED CPR AND INTUBATED. TRANSFERRED TO SICU." PATIENT'S CONDITION REPORTED AS CRITICAL AT THE TIME OF THIS REPORT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11696241 ↗
• MalfunctionJan 29, 2021Retraction Problem

  WHEN TRIMMING PICC FOR PLACEMENT, I RETRACTED THE VPS WIRE. IT BEGAN TO GATHER IN CENTER OF THE PICC DURING RETRACTION IN AN ACCORDION LIKE FASHION. UPON INSPECTION, IT WAS NOTED TO HAVE TWO FLATTENED CRIMPS IN PICC. NEW PICC OBTAINED FOR PROCEDURE, NO INJURY TO PATIENT, BUT POSSIBLY A MANUFACTURING ISSUE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11261178 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153487. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2024 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Ter
• Z-1807-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44063 VPS2
• Z-1808-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 VPS2
• Z-1810-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2
• Z-1365-2019 · Dec 13, 2018 · Terminated
  Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a
• Z-1366-2019 · Dec 13, 2018 · Terminated
  Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a
• Z-3200-2018 · Jul 17, 2018 · Terminated
  5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
• Z-3199-2018 · Jul 17, 2018 · Terminated
  4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2