ARROW IPN033540Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801902095787), received between Jun 3, 2021 and Jul 10, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (4 reports).

11 other recalls cover devices cleared under the same FDA submission (K112896); 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Material Separation; Material Separation

  IT WAS REPORTED " ONE EXTENSION LUMEN WAS OUT DUE TO SHARP EDGE OF PINCH CLAMP." THE PICC WILL BE REPLACED ON A FUTURE DATE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DISCHARGED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468136 ↗
• MalfunctionMar 22, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: THE DOCTOR HAS BEEN HAVING ISSUES WITH THE PEEL AWAY SHEATH IN THE IR PICC KITS. HE CAN CRACK IT FINE BUT ITS NOT "PEELING" AWAY, ITS MORE LIKE SHREDDING. HE HAS TO PULL THE PICC OUT AND TRY TO USE A HEMOSTAT TO TRY TO GRAB THE SHEATH AND PULL IT OUT THAT WAY. THIS SAME ISSUE HAS HAPPENED 4-5 TIMES NOW. ASSOCIATED COMPLAINTS: 9680794-2024-00269, 9680794-2024-00270, 9680794-2024-00271, 9680794-2024-00272 AND 9680794-2024-00273.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960340 ↗
• MalfunctionMar 22, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: THE DOCTOR HAS BEEN HAVING ISSUES WITH THE PEEL AWAY SHEATH IN THE IR PICC KITS. HE CAN CRACK IT FINE BUT ITS NOT "PEELING" AWAY, ITS MORE LIKE SHREDDING. HE HAS TO PULL THE PICC OUT AND TRY TO USE A HEMOSTAT TO TRY TO GRAB THE SHEATH AND PULL IT OUT THAT WAY. THIS SAME ISSUE HAS HAPPENED 4-5 TIMES NOW. ASSOCIATED COMPLAINTS:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960308 ↗
• MalfunctionMar 22, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: THE DOCTOR HAS BEEN HAVING ISSUES WITH THE PEEL AWAY SHEATH IN THE IR PICC KITS. HE CAN CRACK IT FINE BUT ITS NOT "PEELING" AWAY, ITS MORE LIKE SHREDDING. HE HAS TO PULL THE PICC OUT AND TRY TO USE A HEMOSTAT TO TRY TO GRAB THE SHEATH AND PULL IT OUT THAT WAY. THIS SAME ISSUE HAS HAPPENED 4-5 TIMES NOW. ASSOCIATED COMPLAINTS: 9680794-2024-00269, 9680794-2024-00270, 9680794-2024-00271, 9680794-2024-00272 AND 9680794-2024-00273.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959886 ↗
• MalfunctionMar 22, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT: THE DOCTOR HAS BEEN HAVING ISSUES WITH THE PEEL AWAY SHEATH IN THE IR PICC KITS. HE CAN CRACK IT FINE BUT ITS NOT "PEELING" AWAY, ITS MORE LIKE SHREDDING. HE HAS TO PULL THE PICC OUT AND TRY TO USE A HEMOSTAT TO TRY TO GRAB THE SHEATH AND PULL IT OUT THAT WAY. THIS SAME ISSUE HAS HAPPENED 4-5 TIMES NOW. ASSOCIATED COMPLAINTS: 9680794-2024-00269, 9680794-2024-00270, 9680794-2024-00271, 9680794-2024-00272 AND 9680794-2024-00273.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959821 ↗
• MalfunctionMar 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: "WHEN THE DOCTOR TRIED TO INSERT THE INTRODUCER SHEATH WITH DILATOR THE DILATOR DID NOT PASS OVER THE GUIDEWIRE." AFTER RECEIPT OF THE DEVICE AND ITS INITIAL INVESTIGATION, CLARIFICATION WAS SENT OUT TO THE CUSTOMER. THE CUSTOMER CONFIRMED THEY WERE AWARE OF THE CRIMPED PEEL-AWAY. ADDITIONAL COMPLAINT CREATED. ASSOCIATED COMPLAINTS: 9680794-2024-00228 . CLINICAL CONSEQUENCES: NO CLINICAL CONSEQUENCES". NO INJURY TO THE PATIENT. NO DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920363 ↗
• MalfunctionFeb 22, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: WHEN THE PHYSICIAN TRIED TO INSERT THE INTRODUCER SHEATH WITH DILATOR THE DILATOR NOT PASSING OVER THE GUIDEWIRE. CLINICAL CONSEQUENCES: NO CLINICAL CONSEQUENCES". NO INJURY TO THE PATIENT; NO DELAY IN TREATMENT; NO DAMAGE TO THE WIRE. ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED BY THE ACCOUNT NEARLY 2 YEARS LATER. IT IS OBSERVED TO BE DAMAGED. THE COMPLAINT HAS BEEN REOPENED AND CHANGED TO REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757201 ↗
• MalfunctionFeb 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: PICC SHEATH "FALLING APART UPON INSERTION" THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE." NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730562 ↗
• MalfunctionOct 11, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: A PICC LINE GOT BLOCKED ON THE SECOND DAY, AND THEY HAD TO REMOVE THE CATHETER. THERE WAS NO KINKS OR BENDS IN THE CATHETER. THE CATHETER WAS REMOVED AND NEW ONE WAS PLACED SUCCESSFULLY. THERE WAS A DELAY IN THERAPY REPORTED BUT NO OTHER HARM OR CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912368 ↗
• MalfunctionJul 30, 2021Break; Break

  THE COMPLAINT IS REPORTED AS: WING BROKE OFF FROM THE PEEL-AWAY SHEATH. NO MEDICAL INTERVENTION REQUIRED. THE USER HAD TO PULL A LITTLE PART OF THE PICC OUT WITH THE PEEL-AWAY AND REMOVE IT FROM THE PICC. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253295 ↗
• MalfunctionJun 3, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PICC WAS DIFFICULT TO PUSH INTO THE SHEATH INTRODUCER, AT TIME OF REMOVAL ONE WING BROKE FROM THE PEEL-AWAY SHEATH. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932239 ↗
• MalfunctionJun 3, 2021Break; Break

  PICC WAS DIFFICULT TO PUSH INTO THE SHEATH INTRODUCER, AT TIME OF REMOVAL ONE WING BROKE FROM THE PEEL-AWAY SHEATH. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931571 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112896. One submission often covers many models, so check the product and lot details in each record.

• Z-2378-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR
• Z-1822-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45552 HPHNM
• Z-1811-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
• Z-1820-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
• Z-1819-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL
• Z-1327-2018 · Dec 22, 2017 · Terminated
  Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
• Z-0996-2018 · Nov 27, 2017 · Terminated
  Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow CVC is indicated to provide short-ter
• Z-2698-2017 · Jun 12, 2017 · Terminated
  Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
• Z-2331-2017 · May 9, 2017 · Terminated
  1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for
• Z-1705-2017 · Mar 3, 2017 · Terminated
  The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
• Z-0207-2016 · Oct 16, 2015 · Terminated
  ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS