ARROW IPN039773Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902145779), received between Jul 13, 2023 and Apr 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K103255); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Frayed

  IT WAS REPORTED, "STYLET TIP COMPROMISED, WIRE COMING LOOSE." GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND TO ASSESS WHETHER ANY PATIENT HARM, INJURY, OR ADVERSE HEALTH CONSEQUENCES OCCURRED. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE ACCOUNT; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 25024000 ↗
• MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "STYLET WAS PLACED IN A BD DOUBLE LUMEN 4FR PICC AND PICC WAS PLACED. AFTER BBE WAS ACHIEVED THEY WERE PULLING THE STYLET OUT OF THE PICC AND THEY NOTICED THE TIP OF THE VPS STYLET WAS SPLIT. THE PATIENT IS FINE AND NOTHING FELL OFF THE STYLET." THERE WAS 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 22396505 ↗
• MalfunctionNov 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT: UNABLE TO GET BLUE BULLS' EYE DESPITE HAVE GOOD WAVE FORMS. THE PATIENT LOST A SMALL AMOUNT OF BLOOD, AND THE PROCEDURE WAS PROLONGED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18216038 ↗
• MalfunctionNov 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem

  IT WAS REPORTED THAT: LOW AMPLITUDE AND INCONSISTENT DOPPLER WAVEFORM AND UNABLE TO GET BULLSEYE. CHEST X-RAY WAS NEEDED TO CONFIRM PICC POSITION. 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 18215405 ↗
• MalfunctionSep 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT FROM AHS CANADA RECEIVED: PATIENT HAD A PICC FROM ANOTHER MANUFACTURER BRAND INSERTED ON JUNE 23RD UTILIZING TELEFLEX VPS G4 TECHNOLOGY. AS PER PICC RECORD "TIP CONFIRMED IN THE LOWER 1/3 SVC/CAJ AS PER G4 TECHNOLOGY." PICC SLUGGISH TO FLUSH WITH NO BLOOD RETURN PRESENT FROM BOTH PICC LUMENS. WITHDRAWAL OCCLUSION PRESENT TO BOTH PICC LUMENS. CHEST X-RAY WAS DONE AND TIP OF PICC WAS MALPOSITIONED AND LOCATED IN THE MID SVC. EXTERNAL LENGTH OF THE PICC HAD NOT CHANGED AND REMAINED THE SAME AS INSERTION. THE TELEFLEX VPS G4 TECHNOLOGY UTILIZED DURING THE INSERTION HAD THE RESULT THAT THE PICC TIP WAS IN THE LOWER 1/3 SVC (BLUE BULLSEYE OBTAINED), BUT THE CHEST XRAY SHOWED THE PICC TIP WAS NOT IN THE LOWER 1/3 SVC BUT IN THE MID SVC. IT WAS REPORTED ALTHOUGH THE MID SVC IS NOT AN OPTIMAL PICC TIP POSITION, IT WAS STILL SAFE TO TREAT THE WITHDRAWAL OCCLUSION WITH CATH-FLO, AS A WITHDRAWAL OCCLUSION CANNOT BE LEFT UNTREATED. A PICC EXCHANGE OR NEW PICC WAS NOT INSERTED AT THIS TIME AS THE PATIENT HAD LIMITED DURATION LEFT FOR HIS ANTIBIOTICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826361 ↗
• MalfunctionJul 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED PATIENT'S PICC WAS 8CM DEEP IN THE VENTRICLE. THE BULLSEYE SHOWED DESPITE DEEP PLACEMENT. UPON CT SCAN, A CHEST X-RAY WAS ORDERED AND FOUND THE TIP 8CM IN THE VENTRICLE. THE PICC TEAM WAS ASKED TO RETRACT THE PICC 12CMS. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321409 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103255. One submission often covers many models, so check the product and lot details in each record.

• Z-0179-2018 · Jun 1, 2017 · Terminated
  Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately
• Z-2170-2017 · Apr 28, 2017 · Terminated
  Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
• Z-2489-2015 · Jul 30, 2015 · Terminated
  Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound