ARROW IPN924169Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10801902208733), received between Nov 20, 2023 and Jan 27, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2370-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "PICC PLACED ON (B)(6) WITHOUT EVENT AND FOR TPN. PT RETURNED TO THE ED ON (B)(6) 2025 REPORTING PICC LINE WAS PAINFUL, UNABLE TO FLUSH LINE, AND OCCLUSION WARNINGS ON TPN PUMP WERE OCCURRING. WHEN PAIN DURING FLUSHING WAS EXPERIENCED BY PATIENT, RN REMOVED THE LINE. THE PATIENT WAS DIAGNOSED WITH A DVT (SHE ALSO HAD A PRIOR HISTORY OF DVT). UPON EXAMINATION OF THE CATHETER BETWEEN THE 0 AND 1 MARK, THE CATHETER MATERIAL IS NOTED TO BE VERY THIN. THE PICC LINE HAD 2CM EXTERNAL." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 24190882 ↗
• MalfunctionJan 27, 2026Break; Material Deformation

  IT WAS REPORTED THAT "PEEL AWAY SHEATH IS FLOWERING AND MAKING IT DIFFICULT TO REMOVE. SMALL PIECES BROKE OFF OF THE SHEATH WHEN PEELING AWAY. ALL PIECES REMOVED FROM PATIENT. CLINICIAN HAD TO USE A SCALPEL TO NICK IN ORDER TO INSERT THE PEEL AWAY SHEATH." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Laceration(s)

  MAUDE report 24190212 ↗
• MalfunctionJul 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "DURING PICC LINE PLACEMENT THE PEEL-AWAY SHEATH SHEARED DURING PLACEMENT. AN MST KIT WAS OPENED TO OBTAIN ANOTHER PEEL-AWAY SHEATH WHICH WAS SUCCESSFULLY PLACED. THE PATIENT WAS IN HER 20'S AND HAD 'TOUGH' SKIN AND IT WAS DIFFICULT TO ACCESS HER VEIN SECONDARY TO MOVING/TOUGHNESS OF VESSEL WALL." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. A REPLACEMENT SHEATH WAS USED WITHOUT INCIDENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436227 ↗
• MalfunctionMay 14, 2025Crack; Crack

  IT WAS REPORTED "PICC INSERTER NOTED CRACK IN PEEL AWAY SHEATH UPON EXAMINATION PRIOR TO PLACING REMOVED FROM STERILE FIELD AND NEW PEEL AWAY SHEATH USED." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018227 ↗
• MalfunctionJan 16, 2025Material Separation; Material Separation

  IT WAS REPORTED "UNABLE TO THREAD PICC LINE PAST LENGTH OF INTRODUCER, WHEN PULLED OUT PICC LINE, THE STYLET WAS NOTED TO BE PAST THE CATHETER AND BENT AT A 90-DEGREE ANGLE. SUDDENLY, THE PART OF THE STYLET THAT WAS BENT BROKE OFF OUTSIDE OF THE PATIENT. THE LENGTH OF THE NAVICURVE WAS COMPARED TO AN INTACT NAVICURVE TO ENSURE THERE WAS NO WIRE LEFT BEHIND IN THE PATIENT". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168959 ↗
• MalfunctionOct 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "TWISTED CATHETER NOTICED WHEN OVER WIRE FOR A NEW CATHETER BECAUSE LINE WAS PULLED OUT SLIGHTLY." A CHEST XRAY WAS OBTAINED TO DETERMINE THE PICC TIP LOCATION. THE PICC LINE WAS REMOVED AND REPLACED. IT WAS REPORTED "THE PATIENT REMAINED STABLE AND HAD A NEW PICC REPLACED BY OUR TEAM ON (B)(6) 2024. THE PATIENT THEN DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385375 ↗
• MalfunctionJul 10, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT: "RIGHT CEPHALIC VEIN ACCESSED BUT UNABLE TO THREAD CATHETER BEYOND SHOULDER. SOFT TIPPED THE LINE SEVERAL TIMES IN ATTEMPT TO THREAD FURTHER WITHOUT SUCCESS. PICC REMOVED FROM INTRODUCER AND WIRE WAS EXTENDING BEYOND THE LENGTH OF CATHETER, WITH WIRE BENT. AXILLARY WIRE PLACED IN CATHETER. WHILE FLUSHING PINK LUMEN, BLOOD BEGAN TO POOL IN THE WHITE LUMEN INDICATING COMMUNICATION BETWEEN THE LUMENS. LINE WAS REMOVED DUE TO POSSIBLE INTERNAL FRACTURE. SAMPLE INCLUDES PICC AND WIRE. A SECOND KIT WAS OPENED TO COMPLETE THE PROCEDURE. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED." ASSOCIATED COMPLAINT 9680794-2024-00660.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709224 ↗
• MalfunctionJul 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED " RIGHT BRACHIAL VEIN ACCESSED JUST ABOVE ANTECUBITAL VEIN. PICC THREADED WITHOUT DIFFICULTY. DISCREPANCY OF 10 CM BETWEEN EXTERNAL MEASUREMEND REQUIRED A CHEST X- RAY TO VERIFY TIP POSITION. CXR WAS TAKEN AND RADIOLOGIST SAID LINE APPEARED TO BE MID-SVC. 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 19704990 ↗
• MalfunctionJul 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE TEAM WAS PULLING THE INTRODUCER APART AFTER THEY PLACED A LINE AND IT BROKE APART WHILE STILL IN THE PATIENT. SHE STATES THAT THEY HAD TO USE FORCEPS TO REMOVE THE REST OF THE INTRODUCER. THE ENTIRE PEEL-AWAY SHEATH WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CMPLETED SUCCESSSFULLY. NO HARM, INJURY OR HEALTH CONSEQUENCES OCCURRED FROM THIS EVENT. PATIENT IS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19643117 ↗
• MalfunctionFeb 6, 2024Material Separation; Material Separation

  IT WAS REPORTED "THE PEEL AWAY PART OF THE SHEATH SNAPPED WHEN THE WIRE WAS GETTING REMOVED. THERE WAS STILL WIRE IN WHEN THE SHEATH SNAPPED. THEY WERE ABLE TO GET THE WHOLE GLIDE THRU SHEATH OUT." 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 18652117 ↗
• MalfunctionNov 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE "CLINICIAN NOTICED THE TIP OF THE SHEATH OVER THE DILATOR BUCKLE WHEN INSERTING IT OVER THE GUIDEWIRE. THE CLINICIAN WAS ABLE TO INSERT IT ALL THE WAY WITH NO ISSUES BUT DID SEE IT BUCKLE. [THE DEVICE WAS PLACED IN THE] LEFT UPPER ARM, NO SCAR TISSUE [NOTED], SKIN WAS NOT TOUGH. NO ISSUES GAINING ACCESS. [ISSUE WAS IDENTIFIED] PRIOR TO ADVANCING SHEATH. CLINICIAN DID NOT USE A NEW KIT. WHEN SHE ADVANCED THE SHEATH [SHE] NOTICED IT BUCKLE AT THE TIP OF THE SHEATH. THE SHEATH WAS REMOVED IN ITS ENTIRETY." NO PATIENT INJURY, HARM, OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18176157 ↗