ARROW IPN037304Recalls & reported problems
Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen PICC pre-loaded with Arrow(R) VPS Precision(TM) Stylet · Class 2 · Implant
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 60801902120740), received between Nov 2, 2021 and Feb 7, 2025 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (6 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping6
- Break2
- Component Misassembled1
- Difficult to Advance1
- Material Separation1
- Patient Device Interaction Problem1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Anaphylactic Shock1
- Cardiac Arrest1
- Hypersensitivity/Allergic reaction1
- Rash1
- Vomiting1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE CATHETER WAS PLACED MIDARM IN THE BRACHIAL VEIN AND SECURED WITH A STAT-LOCK. THE NEXT DAY, THE PATIENT WAS SITTING IN HIS CHAIR WHEN THE NURSE CAME IN AND SAW IT BLEEDING. THE LINE COMPLETELY SEPARATED FROM THE PINK LUMEN. NURSE REPORTS THAT IT WAS POSSIBLE THAT IT WAS TUGGED ON/PULLED WHEN THE PATIENT WAS UP IN THE CHAIR BUT DOES NOT BELIEVE IT SHOULD HAVE BEEN ENOUGH FORCE TO BREAK OFF. THE PATIENT IS FINE AND HAD NO HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332157 ↗InjuryFeb 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT: THE PATIENT HAD AN ANAPHYLACTIC REACTION. THEY WERE RESUSCITATED IN THE ICU. ADDITIONAL INFORMATION: CLINICIAN STATES HE WAS CRITICAL, BUT IS NOW FINE. PATIENT WAS EXTUBATED (B)(6) 2023.
Patient problems: Anaphylactic Shock; Cardiac Arrest; Hypersensitivity/Allergic reaction; Rash; Vomiting
MAUDE report 18788501 ↗MalfunctionOct 1, 2023Break; Break
IT WAS REPORTED WHILE ATTEMPTING TO PEEL THE PEEL-AWAY SHEATH, ONE SIDE OF THE WHITE SHEATH HUB BROKE OFF. CLINICIAN USED THE LEVERAGE OF THE PICC AND ONE WHITE WING TO CONTINUE TO PEEL THE SHEATH EVEN THOUGH THE OTHER WHITE HUB BROKE OFF. PROCEDURE COMPLETED WITHOUT NEEDING TO DROP AN ADDITIONAL SHEATH. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849435 ↗MalfunctionJun 2, 2022Break; Break
IT WAS REPORTED THE TAB BROKE OFF THE PEEL-AWAY SHEATH DURING REMOVAL. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14577522 ↗MalfunctionDec 28, 2021Component Misassembled; Component Misassembled
WHEN GOING TO PLACE A SINGLE LUMEN PICC, THE USER FOUND THE KIT HAD A TRIPLE LUMEN CATHETER INSTEAD OF THE SINGLE LUMEN CATHETER. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13093384 ↗MalfunctionDec 21, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking
PICC WOULD NOT PASS THROUGH THE PEEL-AWAY SHEATH. THEY OPENED A SEPARATE 5.5 FR SHEATH, THROUGH WHICH THEY INSERTED THE CATHETER. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13055394 ↗MalfunctionDec 2, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
PRIOR TO INSERTION RN OPENED SINGLE LUMEN KIT AND FOUND THERE WAS A TRIPLE LUMEN PICC IN KIT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12920508 ↗MalfunctionNov 18, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
PRIOR TO INSERTION RN OPENED SINGLE LUMEN KIT AND FOUND THERE WAS A TRIPLE LUMEN PICC IN KIT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12838470 ↗MalfunctionNov 2, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
CUSTOMER OPENED THE KITS AND THEY HAD TRIPLE LUMEN PICCS IN THEM, NOT SINGLE LUMENS AS THEY WERE LABELED. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12740220 ↗MalfunctionNov 2, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
CUSTOMER OPENED THE KITS AND THEY HAD TRIPLE LUMEN PICCS IN THEM, NOT SINGLE LUMENS AS THEY WERE LABELED. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12740185 ↗MalfunctionNov 2, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
CUSTOMER OPENED THE KITS AND THEY HAD TRIPLE LUMEN PICCS IN THEM, NOT SINGLE LUMENS AS THEY WERE LABELED. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12740070 ↗MalfunctionNov 2, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
CUSTOMER OPENED THE KITS AND THEY HAD TRIPLE LUMEN PICCS IN THEM, NOT SINGLE LUMENS AS THEY WERE LABELED. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12740024 ↗
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, ClassifiedArrow 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-1808-2019 · Apr 23, 2019 · TerminatedArrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 VPS2
- Z-1810-2019 · Apr 23, 2019 · TerminatedArrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2
- Z-1807-2019 · Apr 23, 2019 · TerminatedArrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44063 VPS2
- Z-1366-2019 · Dec 13, 2018 · TerminatedArrow 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-1365-2019 · Dec 13, 2018 · TerminatedArrow 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-3200-2018 · Jul 17, 2018 · Terminated5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
- Z-3199-2018 · Jul 17, 2018 · Terminated4.5 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
Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page