ARROW IPN033564Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801902095848), received between Jul 26, 2023 and Jan 21, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K042126); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Material Puncture/Hole; Device Dislodged or Dislocated; Material Puncture/Hole; Device Dislodged or Dislocated

  IT WAS REPORTED "A CATHETER IS LOCATED IN THE PATIENT, MOISTURE IS EVIDENCED, IT IS DISPLACED, AND A PERFORATION IS EVIDENCED, SO IT IS DECIDED TO WITHDRAW". THE PATIENT HAD BEEN WITH THE CATHETER FOR 4 DAYS (FROM THE ICU), SO IT WAS NOT POST-INSERTION. THE CATHETER PERFORATION IS EVIDENT 5 CENTIMETRES FROM THE INSERTION SITE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21196000 ↗
• MalfunctionDec 6, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "THE PROCEDURE OF PASSING A PERIPHERAL INSERTION CENTRAL CATHETER - PICC TO THE PATIENT IS PERFORMED, THEY OBSERVE THAT THERE IS NO BLOOD RETURN, THEY EVALUATE THE CATHETER POSITIONING , WITHOUT FINDING ANY EVENTUALITY, WHEN THERE IS NO RETURN, THEY REMOVE IT AND TRY WITH ANOTHER CATHETER WITH WHICH THEY OBTAIN IMMEDIATE RETURN. THE EXTRACTED CATHETER IS TESTED FOR PERMEABILITY, FINDING AN UNUSUAL RESISTANCE, IT IS NECESSARY TO MAKE A LOT OF FORCE TO THE EMBOLUS AND THE AMOUNT THAT PASSES IS MINIMAL. THIS EVENT IMPLIED A DOUBLE PUNCTURE OF THE PATIENT. THERE WAS NO REPORTED PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863020 ↗
• MalfunctionDec 5, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "THE PROCEDURE OF PASSING A PERIPHERAL INSERTION CENTRAL CATHETER - PICC TO THE PATIENT IS PERFORMED, WHEN PERFORMING THE PROCEDURE, THEY OBSERVE THAT THERE IS NO BLOOD RETURN, THEY EVALUATE THE CATHETER POSITIONING, WITHOUT FINDING ANY EVENTUALITY, WHEN NO RETURN IS OBTAINED, THEY REMOVE IT AND TRY WITH ANOTHER CATHETER WITH WHICH THEY OBTAIN IMMEDIATE RETURN, THE EXTRACTED CATHETER IS TESTED FOR PERMEABILITY, FINDING AN UNUSUAL RESISTANCE, IT IS NECESSARY TO MAKE MUCH FORCE TO THE EMBOLUS AND THE AMOUNT THAT PASSES IS MINIMAL. THIS EVENT IMPLIED THE DOUBLE PUNCTURE OF THE PATIENT. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE WITH NO HARM REPORTED." ASSOCIATED COMPLAINTS 9680794-2024-01205, AND 9680794-2024-01200.

  Patient problems: Insufficient Information

  MAUDE report 20853757 ↗
• MalfunctionDec 5, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "THE PROCEDURE OF PASSING A PERIPHERAL INSERTION CENTRAL CATHETER - PICC. TO THE PATIENT IS PERFORMED, WHEN PERFORMING THE PROCEDURE, THEY OBSERVE THAT THERE IS NO BLOOD RETURN, THEY EVALUATE THE CATHETER POSITIONING, WITHOUT FINDING ANY EVENTUALITY, WHEN NO RETURN IS OBTAINED, THEY REMOVE IT AND TRY WITH ANOTHER CATHETER WITH WHICH THEY OBTAIN IMMEDIATE RETURN, THE EXTRACTED CATHETER IS TESTED FOR PERMEABILITY, FINDING AN UNUSUAL RESISTANCE, IT IS NECESSARY TO MAKE MUCH FORCE TO THE EMBOLUS AND THE AMOUNT THAT PASSES IS MINIMAL. THIS EVENT IMPLIED THE DOUBLE PUNCTURE OF THE PATIENT. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE WITH NO HARM REPORTED." ASSOCIATED COMPLAINTS 9680794-2024-01203 AND 9680794-2024-01200.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853481 ↗
• MalfunctionDec 5, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "THE PROCEDURE OF PASSING A PERIPHERAL INSERTION CENTRAL CATHETER - PICC TO THE PATIENT IS PERFORMED, WHEN PERFORMING THE PROCEDURE, THEY OBSERVE THAT THERE IS NO BLOOD RETURN, THEY EVALUATE THE CATHETER POSITIONING, WITHOUT FINDING ANY EVENTUALITY, WHEN NO RETURN IS OBTAINED, THEY REMOVE IT AND TRY WITH ANOTHER CATHETER WITH WHICH THEY OBTAIN IMMEDIATE RETURN, THE EXTRACTED CATHETER IS TESTED FOR PERMEABILITY, FINDING AN UNUSUAL RESISTANCE, IT IS NECESSARY TO MAKE MUCH FORCE TO THE EMBOLUS AND THE AMOUNT THAT PASSES IS MINIMAL. THIS EVENT IMPLIED THE DOUBLE PUNCTURE OF THE PATIENT. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE WITH NO HARM REPORTED." ASSOCIATED COMPLAINTS: 9680794-2024-01205, 9680794-2024-01203.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853123 ↗
• InjuryNov 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "PCC BILUMEN CATHETER IS PASSED TO GUARANTEE MEDICAL TREATMENT OF 44 DAYS IN THE LEFT UPPER LIMB WITHOUT COMPLICATION, IT IS EVIDENCED BY X- RAYS THAT IT HAS BEEN ANGLED WHY IT IS DECIDED TO ACCOMMODATE THE CONTROL X-RAY CONTINUES TO SHOW THE ACODE IT IS DECIDED TO WITHDRAW EVIDENCING THAT IT COMES OUT ELBOWED AND CANNOT BE REMOVED THROUGH THE INSERTION POINT IT IS INDICATED TO THE DOCTOR WHO DETERMINES EVALUATION BY PERIPHERAL VASCULAR CX TO REMOVE IT." ADDITIONAL INFORMATION REPORTS THERE WAS "DAMAGE TO THE INTIMAL LAYER OF THE VEIN IN THE CATHETER PATH." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Vascular Dissection

  MAUDE report 20684633 ↗
• MalfunctionJul 26, 2023Material Separation; Material Separation

  IT WAS REPORTED WHEN ADMINISTERING MEDICATION THROUGH THE BILUMEN PICC, ONE OF THE PORTS WAS FOUND COVERED WITH ADHESIVE TAPE AND THE DISTAL CONNECTOR OF THE PICC BROKEN. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042126. 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-2825-2015 · Aug 27, 2015 · Terminated
  Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
• Z-1503-2009 · Feb 11, 2009 · Terminated
  Arrow Peripherally Inserted Central Catheter