ARROW IPN055872Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902159974), received between Nov 29, 2023 and Oct 30, 2024 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K153487); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A RISK MANAGER FOR THE HEALTH CARE FACILITY SENT TO TELEFLEX THE FOLLOWING NOTES FROM A NURSE AT THE HEALTH CARE FACILITY, "FOLLOWING DRESSING PLACEMENT ON PICC LINE, PATIENT BEGAN TO COMPLAIN OF ITCHING 'ALL OVER'. SHE ALSO COMPLAINED OF STRONG SALINE TASTE WITH FLUSH. THE 'ITCHING' GOT WORSE AND PATIENT BEGAN TO LOOK ACUTELY UNCOMFORTABLE IN THE BED. REMOVED STERILE DRAPING AND PATIENT REPORTED CONTINUING TO FEEL WORSE. AT THIS TIME, I WENT AND FOUND CHARGE NURSE AS PRIMARY NURSE WAS NOT AT THE DESK. UPON RETURNING TO THE ROOM, THE PATIENT WAS NOT RESPONDING TO VERBAL CUES AND WAS NOW NOTED TO BE DIAPHORETIC. AT THIS TIME, I CALLED OUT FOR RRT TO BE NOTIFIED. PT APPEARED TO BE AGITATED AND POSSIBLE SZ ACTIVITY. DEVIATION TO R AND POSTURING, APENIC AND PULSELESSNESS> ACLS> ROSC>." THAT SAME RISK MANAGER FOR THE HEALTH CARE FACILITY ALSO SENT TO TELEFLEX THE FOLLOWING NOTES FROM THE RRT REFERENCED ABOVE, "ON ARRIVAL TO PT ROOM, PT WAS MAINTAINING AIRWAY INDEPENDENTLY AND WAS ONLY RESPONDING TO PAINFUL STIMULI, WHILE ASSESSING FOR VITALS PATIENT WENT UNRESPONSIVE AND BECAME APNEIC. AT THAT POINT RESPIRATORY STARTED TO BAG AND WITH PULSE CHECK WE BEGAN COMPRESSIONS AN

  Patient problems: Insufficient Information

  MAUDE report 20570242 ↗
• InjuryMay 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY CLINICAL STAFF IN THE HOSPITAL THAT: THE PATIENT WAS ADMITTED FOR OSTEOMYELITIS ON (B)(6) 2024. HE WAS GETTING IV ANTIBIOTICS. ON (B)(6) 2024 A PICC LINE WAS BEING PLACED. THE RN PRESENT AT THE PROCEDURE, NOTE IS AS FOLLOWS: "AFTER INFORMED, WRITTEN CONSENT, A PREPROCEDURAL TIMEOUT WAS PERFORMED. BILATERAL ARMS BATHED WITH CHG WIPES FROM AXILLA TO FINGERTIPS, PRIOR TO PREPPING AND DRAPING PATIENT FOR PROCEDURE. ARM CIRCUMFERENCE AT INSERTION SITE WAS 28 CM. THE PATIENT'S LEFT ARM WAS PREPPED AND DRAPED IN STERILE FASHION. LOCAL ANESTHESIA WAS OBTAINED WITH 1.5 ML OF 1% LIDOCAINE. USING ULTRASOUND GUIDANCE, THE BRACHIAL VEIN WAS ACCESSED USING MICRO PUNCTURE TECHNIQUE X 1 ATTEMPT. A GUIDE WIRE WAS INTRODUCED INTO THE NEEDLE. THE NEEDLE WAS REMOVED, A 4.5 FRENCH PEEL- AWAY SHEATH WAS PLACED OVER THE WIRE AND THEN THE WIRE WAS REMOVED. A 52 CM, SINGLE LUMEN CATHETER WAS ADVANCED THROUGH THE PEEL-AWAY SHEATH AND THE SHEATH WAS REMOVED. FOLLOWING INSERTION, PATIENT COMPLAINED OF NAUSEA, WAS ABLE TO FOLLOW COMMANDS AND TURN HIS HEAD TO THE RIGHT AND HAD CLEAR EMESIS NOTED. HE BEGAN TO COMPLAIN OF "BURNING IN HIS BELLY" AND WITHIN 30 SECONDS WAS COMPLAINING OF GLOBAL IT

  Patient problems: Burning Sensation; Diaphoresis; Increased Respiratory Rate; Itching Sensation; Nausea

  MAUDE report 19379569 ↗
• MalfunctionNov 29, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: THERE WAS RESISTANCE WHEN ATTEMPTING TO PASS THE WIRE THROUGH THE NEEDLE. WHEN IT WAS REMOVED THE WIRE WAS UNRAVELLED. 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 18225868 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153487. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2024 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Ter
• Z-1810-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2
• Z-1808-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 VPS2
• Z-1807-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44063 VPS2
• Z-1366-2019 · Dec 13, 2018 · Terminated
  Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a
• Z-1365-2019 · Dec 13, 2018 · Terminated
  Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a
• Z-3199-2018 · Jul 17, 2018 · Terminated
  4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
• Z-3200-2018 · Jul 17, 2018 · Terminated
  5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2