ARROW IPN037697 (REF CDC-41541-MPK1A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 50801902130155), received between May 3, 2021 and Aug 4, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K161313); 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.

• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "AFTER INSERTION OF THE MIDLINE USING 4.5 F CATH, THE PATIENT WAS GETTING READY TO BE TRANSPORTED BACK TO HER UNIT, THE PATIENT INDICATED TO THE NURSE THAT SHE WAS HAVING SHORTNESS OF BREATH, FACIAL FLUSHING, LIPS AND TONGUE SWELLING". ADDITIONAL INFORMATION RECEIVED STATES "PATIENTS DEVELOPED SHORTNESS OF BREATH, LOW BLOOD PRESSURE, AND THROAT TIGHTNESS. RAPID RESPONSE WAS ACTIVATED AND THE PATIENT RECOVERED." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DISCHARGED".

  Patient problems: Dyspnea; Low Blood Pressure/ Hypotension; Swelling/ Edema

  MAUDE report 22699103 ↗
• MalfunctionMar 25, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT: THE INTRODUCER STARTED PEELING BACK AT THE EDGE OF THE OUTSIDE PIECE, MAKING IT DIFFICULT TO INSERT THE WHOLE DEVICE INTO THE VESSEL. ADDITIONAL INFORMATION: WHEN THE CLINICIAN ATTEMPTED TO PEEL AWAY THE SHEATH ONE OF THE WHITE TABS BROKE OFF. THEY WERE ABLE TO PULL IT BACK A BIT AND CAREFULLY PEEL AWAY THE INTRODUCER FROM THE CATHETER WITH THE ONE HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: Pain; Skin Tears

  MAUDE report 18968444 ↗
• MalfunctionMar 25, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "BROKE APART WHILE IN THE PATIENT AND WAS VERY DIFFICULT TO REMOVE, AS ONE OF THE WINGS ON THE WHITE BREAKAWAY SIDES SEPARATED FROM THE REST OF IT." ADDITIONAL INFORMATION: WHEN THE CLINICIAN ATTEMPTED TO PEAL AWAY THE SHEATH ONE OF THE WHITE TABS BROKE OFF. THEY WERE ABLE TO PULL IT BACK A BIT AND CAREFULLY PEAL AWAY THE INTRODUCER FROM THE CATHETER WITH THE ONE HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: Pain; Skin Tears

  MAUDE report 18968382 ↗
• InjuryMar 25, 2023Break; Break

  IT WAS REPORTED "THE PEEL AWAY SHEATH TABS BROKE AWAY FROM THE SHEATH. THE SHEATH WAS DISLODGED IN THE BODY REQUIRING SURGICAL INTERVENTION TO REMOVED." THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16616598 ↗
• MalfunctionMar 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THE CATHETER HUB SEPARATED FROM EXTENSION LINE. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552571 ↗
• MalfunctionFeb 8, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE INTRODUCER HAD A BEND AND THEN STARTED TO BUCKLE UP. PATIENT WAS REPORTED TO HAVE SAGGY THIN SKIN. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327749 ↗
• MalfunctionJul 15, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE PEEL AWAY SHEATH SPLIT WHILE TRYING TO INSERT INTO PATIENT. NO PATIENT HARM WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032767 ↗
• MalfunctionJul 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE COMPLAINT IS REPORTED AS: THE GLIDETHRU SHEATH INTRODUCER IS TIGHT MAKING IT DIFFICULT TO PASS THE WIRE AND THE MIDLINE CATHETER THROUGH THE SHEATH. IT WAS REPORTED THE NURSE WAS ABLE TO PLACE THE PICC AND COMPLETE THE PROCEDURE USING A SINGLE-STERILE SHEATH INTRODUCER MADE BY A COMPETITOR. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196078 ↗
• MalfunctionJul 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "WE HAD A MIDLINE PULL APART ON FRIDAY WAS PLACED ON (B)(6) AND PULLED APART ON (B)(6), REMOVED AND REPLACED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE". MULTIPLE ATTEMPTS REQUESTED TO CUSTOMER FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177394 ↗
• MalfunctionMay 3, 2021Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED THE CATHETER WOULD NOT PROVIDE BLOOD RETURN IMMEDIATELY AFTER PLACEMENT. THE LINE WAS PULLED BACK AND STILL NO BLOOD RETURN. IT WAS REPORTED THE MIDLINE WAS PLACED IN A LARGE, RIGHT BASILIC VESSEL. NO DIFFICULTY DURING INSERTION. THE LINE FLUSHED EASILY AND WAS PRIMED BEFORE INSERTION WITH NO LEAKING NOTED. A NEW KIT WAS OPENED AND THE USER DID AN OVER-WIRE CATHETER EXCHANGE, AND LIKE BEFORE THERE WAS NO BLOOD RETURN ONCE INSERTED, DESPITE RECEIVING BLOOD RETURN WHEN DILATING. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766226 ↗
• MalfunctionMay 3, 2021Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED THE CATHETER WOULD NOT PROVIDE BLOOD RETURN IMMEDIATELY AFTER PLACEMENT. THE LINE WAS PULLED BACK AND STILL NO BLOOD RETURN. IT WAS REPORTED THE MIDLINE WAS PLACED IN A LARGE, RIGHT BASILIC VESSEL. NO DIFFICULTY DURING INSERTION. THE LINE FLUSHED EASILY AND WAS PRIMED BEFORE INSERTION WITH NO LEAKING NOTED. A NEW KIT WAS OPENED AND THE USER DID AN OVER-WIRE CATHETER EXCHANGE, AND LIKE BEFORE THERE WAS NO BLOOD RETURN ONCE INSERTED, DESPITE RECEIVING BLOOD RETURN WHEN DILATING. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766217 ↗
• MalfunctionMay 3, 2021Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED THE CATHETER WOULD NOT PROVIDE BLOOD RETURN IMMEDIATELY AFTER PLACEMENT. THE LINE WAS PULLED BACK AND STILL NO BLOOD RETURN. IT WAS REPORTED THE MIDLINE WAS PLACED IN A LARGE, RIGHT BASILIC VESSEL. NO DIFFICULTY DURING INSERTION. THE LINE FLUSHED EASILY AND WAS PRIMED BEFORE INSERTION WITH NO LEAKING NOTED. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766060 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161313. One submission often covers many models, so check the product and lot details in each record.

• Z-0102-2023 · Sep 14, 2022 · Terminated
  ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intrave
• Z-1818-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS