ARROW IPN037301Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 30801902120794), received between Aug 3, 2020 and Apr 9, 2024 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2024Material Separation; Material Separation

  IT WAS REPORTED "PICC TEAM RECEIVED A CALL FRIDAY THAT HUB HAD FALLEN OFF. THE STAFF MEMBER DID NOT OBSERVE THE HUB FALLING OFF, SHE DISCOVERED IT. PICC NURSE PULLED LINE AND REPLACED WITH A NEW CATHETER." 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 19069431 ↗
• MalfunctionJan 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: PEEL-AWAY SHEATH SEPARATED AT ONE OF THE WHITE TABS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473708 ↗
• MalfunctionJan 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: PEEL-AWAY SHEATH SEPARATED AT ONE OF THE WHITE TABS. IT WAS REMOVED IN ITS ENTIRETY, THERE WAS NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473668 ↗
• MalfunctionOct 25, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE CATHETER KINKED DURING USE. THE CATHETER WAS PLACED ON (B)(6) 2023 IN THE LEFT BRACHIAL. THE CATHETER WAS NOT FLUSHING AND HAD SLUGGISH OR ABSENT BLOOD RETURN. THE PICC WAS FLUSHED HARD AND NO LONGER HAD DIFFICULTY WITH FLUSHING OR BLOOD RETURN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003719 ↗
• MalfunctionOct 25, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE CATHETER KINKED WHILE INDWELLING. THE CATHETER HAD BEEN PLACED ON (B)(6) 2023 IN THE LEFT BASILIC. THE CATHETER WAS NOT FLUSHING AND HAD SLUGGISH OR ABSENT BLOOD RETURN. THE CATHETER WAS PULLED BACK 2 CM AND CORRECT PLACEMENT CONFIRMED USING ULTRASOUND. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003309 ↗
• MalfunctionOct 25, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE CATHETER WAS KINKED WHILE INDWELLING. THE CATHETER WAS PLACED ON (B)(6) 2023 IN THE RIGHT BRACHIAL. THE CATHETER WAS NOT FLUSHING AND HAD SLUGGISH OR ABSENT BLOOD RETURN. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003212 ↗
• MalfunctionOct 24, 2023Stretched; Stretched

  THE COMPLAINT IS REPORTED AS: PATIENT HAD A DOUBLE LUMEN PICC PLACED AROUND AUG 24TH, AT THAT TIME THE PATIENT WAS AN INPATIENT RECEIVING CHEMOTHERAPY DRUGS (CYTARABINE) AND ANTIBIOTICS. THE PT WAS DISCHARGED HOME WITH THE PICC ON SEPT 6TH AND RETURNED TO THE HOSPITAL ON SEPT 24TH, SHE HAD A CT WITH CONTRAST OF THE ABDOMEN AND CHEST THAT WAS DONE ON SEPT 25TH, THE PICC WAS POWER INJECTED@ 3CC PER SECOND WITH 100ML OF CONTRAST. THE PATIENT WAS SENT BACK TO THE UNIT AFTER THE CT AND IT WAS DISCOVERED THE FOLLOWING DAY THAT THE WHITE HUB EXTENSION LINE/PIGTAIL WAS "FLOPPY" AND LOOKED LIKE IT HAD BALLOONED OUT AND COLLAPSED. THE LUMEN WAS STILL FLUSHING AND NOT LEAKING, BUT THE ONCOLOGY CLINICIAN RECOMMENDED NOT TO USE THE WHITE PORT, TO USE THE PINK PORT LUMEN FOR THE REMAINING THERAPY (2 MORE DOSES OF CHEMO WERE TO BE ADMINISTERED ON (B)(6) AND THEN LINE WAS TO BE DISCONTINUED ON THE 30TH. THE PATIENT IS FINE AND HAS NOT HAD ANY ISSUES RELATED TO THE PICC AND HER THERAPY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000169 ↗
• MalfunctionAug 31, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED "CATHETER BENT". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665955 ↗
• InjuryMay 22, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE NURSE USED THE CHG PICC AND UPON INSERTION THE PATIENT STARTED HAVING SYMPTOMS CONSISTENT WITH CHG ALLERGY. PATIENT STARTED FEELING NAUSEOUS, HAVING HEART RATE CHANGES, AND SEIZURE LIKE MOVEMENTS. A CODE WAS CALLED. THE NURSE REMOVED THE CATHETER RIGHT AWAY AND THE SYMPTOMS STARTED TO GO AWAY. THE PATIENT WAS TRANSFERRED TO ICU FOR 2 DAYS OF OBSERVATION. IN (B)(6) 2022, THE PATIENT SAW AN ALLERGIST AND WAS CONFIRMED TO HAVE AN CHG ALLERGY.

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

  MAUDE report 16976283 ↗
• MalfunctionMay 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THE TUBING DETACHED FROM THE HUB DURING USE. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883028 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THE PICC LINE WAS LEAKING FROM THE JUNCTION OF THE CLEAR TUBING AND THE PINK LUER HUB. EARLY IN THE MORNING IT WAS FUNCTIONING APPROPRIATELY FOR A LAB DRAW, BUT ON ASSESSMENT PRIOR TO USE FOR AN INFUSION, IT WAS NOTED TO LEAK. THE LINE HAD BEEN PLACED ON (B)(6) 2023. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742307 ↗
• MalfunctionMar 7, 2023Break; Break

  THE COMPLAINT IS REPORTED AS: "THE HANDLES OF THE GLIDE THRU SHEATH BROKE OFF WHEN TRYING TO CRACK THE SHEATH WHICH LEFT THE SHEATH IN THE TISSUE WHICH THEY HAD TO FISH OUT. THEY GOT IT ALL OUT AND THE PATIENT IS FINE". IT WAS REPORTED THE VASCULAR ACCESS NURSE WHO WAS PLACING THE LINE WAS ABLE TO PULL THE PIECES OF THE SHEATH OUT OF THE PATIENT'S TISSUE WITH "TOOLS SHE HAD". NO PATIENT INJURY OR CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499220 ↗
• MalfunctionSep 19, 2022Material Deformation; Material Deformation

  THE COMPLAINT IS REPORTED AS: "PEELAWAY SHEATH/DILATOR WAS DIFFICULT TO INSERT. THEY WERE UNABLE TO THREAD THE PICC THROUGH THE SHEATH MORE THAN A FEW CENTIMETERS, AND ENDED UP HAVING TO START THE PROCEDURE OVER. WHEN THE DILATOR WAS REMOVED, MULTIPLE JAGGED EDGES CAN BE SEEN ALONG THE MIDDLE ASPECT OF THE DILATOR. THE DILATOR DIDN'T BUCKLE." ADDITIONAL INFORMATION RECEIVED CLARIFIED IT WAS THE "SHEATH/DILATOR" THAT WAS DAMAGED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445417 ↗
• MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC WAS LEAKING AT THE PIGTAIL AND PINK HUB AREA. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009151 ↗
• MalfunctionMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  PICC WAS PLACED ON (B)(6) 2022 IN RIGHT BASILIC WITH 0 CM OUT. ON (B)(6) 2022 THE PICC WAS LEAKING. THE NURSE NOTICED THE DRESSING GETTING WET. THE DRESSING WAS REMOVED AND SAW LEAK. THE NURSE NOTIFIED THE VASCULAR ACCESS TEAM AND THE PICC WAS REPLACED. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311988 ↗
• MalfunctionFeb 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THE PINK HUB CAME OFF OF THE PICC. THE PICC HAD BEEN PLACED ON (B)(6) 2022. IT WAS REPORTED "PATIENT RECEIVED A POWER INJECTION IN CT, THEN THEY POSSIBLY COULD HAVE MOVED PATIENT OVER AND PULLED ON THE PICC EXTENSION, UNSURE WHEN FOUND IN THE BED". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518214 ↗
• MalfunctionJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  PICC LINE WAS PLACED ON (B)(6) 2021. ON THE EVENING OF (B)(6) 2022, THE PICC LINE STARTED LEAKING FROM THE PINK HUB WHEN FLUSHED AND SO THE LINE WAS REMOVED. A NEW PICC LINE WAS PLACED ON (B)(6) 2022. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13371329 ↗
• MalfunctionJan 4, 2022Material Separation; Material Separation

  CATHETER WAS FOUND BY NURSE WITH HUB "SNAPPED CLEAN". NURSE WAS MOVING PATIENT BUT UNSURE HOW IT CAME OFF. CATHETER WAS REPLACED, BUT DEVICE WAS NOT SAVED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151685 ↗
• MalfunctionNov 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  CUSTOMER REPORTS ADVANCING THE CATHETER THROUGH THE SHEATH WAS VERY DIFFICULT AND THE SHEATH HAD TO BE REMOVED ENTIRELY IN ORDER FOR THE LAST FEW CENTIMETERS OF CATHETER TO BE ADVANCED IN THE PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798902 ↗
• MalfunctionJul 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  PICC WAS INSERTED ON (B)(6) APRIL. NURSE ALERTED TO HOLE IN PICC ON 17-JUN. THE PICC WAS DISCONTINUED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249025 ↗
• MalfunctionJul 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: PICC NURSE WAS ALERTED TO A LEAK/HOLE IN PICC PLACED ON 1(B)(6) 2021. THE HOLE IS JUST BENEATH THE PINK HUB. IT WAS REPORTED THE LINE WAS DISCONTINUED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12226907 ↗
• MalfunctionJul 19, 2021Material Puncture/Hole; Material Puncture/Hole

  COMPLAINT FOUND IN MAUDE DATABASE: "PICC WITH MICRO HOLES IN EXTENSION. REQUIRED REPLACEMENT. FDA SAFETY REPORT ID # (B)(4)."

  Patient problems: Insufficient Information

  MAUDE report 12192968 ↗
• InjuryJun 17, 2021Material Rupture; Material Rupture

  THE COMPLAINT IS REPORTED AS: PICC WAS INSERTED ON (B)(6); TODAY THE PATIENT WAS IN CT FOR POWER INJECTION AND STARTED SCREAMING DURING INJECTION. CT IDENTIFIED A BURST. PSI INJECTION FLOW RATE WAS 3. PATIENT WAS REPORTED TO HAVE A BAD INFILTRATION. CATHETER WAS PATENT PRIOR TO CT PER NURSE. IT WAS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED FOR THE INFILTRATION. THE PICC WAS REMOVED AND THE PATIENT WAS PLANNED FOR A TUNNELED IJ.

  Patient problems: Infiltration into Tissue

  MAUDE report 12022155 ↗
• MalfunctionMay 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED LEAKING/HOLE WHERE EXTENSION LINE MEETS THE HUB ON THE PICC LINE. THE DEVICE WAS REPLACED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904377 ↗
• MalfunctionJan 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS "INCIDENT WITH CLAMPS ON LUMEN OF PICC BREAKING/COMING OFF" AND "CAUSING AN INCREASE IN DECLOTTING PICCS BECAUSE OF THE INABILITY TO CLAMP POST FLUSHING". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240250 ↗

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-1810-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2
• 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-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-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-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