ARROW IPN037300 (REF CDC-45052-VPS2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 30801902120756), received between Mar 4, 2021 and Aug 8, 2024 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "UPON INSERTION OF GUIDEWIRE, GUIDEWIRE BECAME TO UNRAVEL CAUSING DIFFICULTY IN REMOVING THE WIRE FROM THE ARM AND NEEDLE. UPON REMOVAL OF THE WIRE, WIRE WAS PHYSICALLY UNRAVELED AND COILED. PATIENT DID NOT HAVE ANY COMPLICATIONS OR PAIN, AND THIS DID NOT HARM THE PATIENT. STAFF HAD TO USE ANOTHER KIT TO PLACE THE LINE IN THIS PATIENT WHICH WAS SUCCESSFUL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943346 ↗
• MalfunctionMay 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "DOUBLE LUMEN PICC IN BASILIC VEIN BEING INSERTED IN PATIENT. DURING PEEL AWAY SHEATH REMOVAL, WHITE TAB BROKE OFF, RN HAD TO USE RAZOR TO SEPARATE BOTH HALFS OF PEEL AWAY SHEATH IN ORDER TO GET A HOLD OF DAMAGED SECTION. NO HARM TO PATIENT. ENTIRETY OF SHEATH WAS REMOVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219268 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED "BOTH TABS BROKE OFF WHEN ATTEMPTING TO PEEL INTRODUCER SHEATH AWAY AT END OF CASE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 19060097 ↗
• MalfunctionMar 21, 2024Material Separation; Material Separation

  IT WAS REPORTED "WHITE PLASTIC THUMB TAB OF PEEL AWAY SHEATH SNAPPED OFF OF THE SHEATH WHILE INSERTING PICC". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949518 ↗
• MalfunctionJun 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THE HUB BROKE OFF THE CATHETER. THE PICC HAD BEEN IN PLACE FOR 4 DAYS. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577811 ↗
• MalfunctionMar 15, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  CUSTOMER REPORTED PICC CATHETER COULD NOT PASS THROUGH THE GLIDETHRU SHEATH. THE CATHETER KEPT GETTING CAUGHT UP IN THE SHEATH WHEN THE SHEATH WAS IN THE PATIENT'S ARM. WHEN SHEATH WAS REMOVED FROM PATIENT AND CATHETER WAS ATTEMPTED THROUGH THE SHEATH OUTSIDE THE PATIENT'S ARM, IT WENT THROUGH. ONCE INSIDE THE PATIENT THE CATHETER WAS UNABLE TO PASS THROUGH. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13775040 ↗
• MalfunctionFeb 23, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  CUSTOMER REPORTED PICC STUCK IN THE GLIDE THRU SHEATH. SQUEAKY SOUND WHEN TRYING TO PUSH THE SHEATH IN OR OUT OF THE PICC. THE CUSTOMER ALSO NOTED THE PICC CATHETER WAS OBLONG SHAPED MEANING MISSHAPED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585408 ↗
• MalfunctionFeb 16, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  COMPLAINT IS REPORTED AS: PICC WAS VERY TIGHT GOING THROUGH THE SHEATH, PICC WASN'T ROUND, LOOKS AND FEELS FLAT IN SPOTS BUT WAS ABLE TO GET IT IN THE PATIENT. THEY HAVE BEEN CHOKING UP AND 'FORCING' THE PICC THROUGH THE SHEATH OR BREAKING THE SHEATH EARLY AND FLOATING THE PICC IN. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541746 ↗
• MalfunctionFeb 16, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  COMPLAINT IS REPORTED AS: PICC WAS VERY TIGHT GOING THROUGH THE SHEATH, PICC WASN'T ROUND, LOOKS AND FEELS FLAT IN SPOTS BUT WAS ABLE TO GET IT IN THE PATIENT. THEY HAVE BEEN CHOKING UP AND 'FORCING' THE PICC THROUGH THE SHEATH OR BREAKING THE SHEATH EARLY AND FLOATING THE PICC IN. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541729 ↗
• MalfunctionFeb 16, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  COMPLAINT IS REPORTED AS: PICC WAS VERY TIGHT GOING THROUGH THE SHEATH, PICC WASN'T ROUND, LOOKS AND FEELS FLAT IN SPOTS BUT WAS ABLE TO GET IT IN THE PATIENT. THEY HAVE BEEN CHOKING UP AND 'FORCING' THE PICC THROUGH THE SHEATH OR BREAKING THE SHEATH EARLY AND FLOATING THE PICC IN. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541677 ↗
• MalfunctionDec 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THE PEEL-AWAY SHEATH WAS BROKEN INTO 4 PIECES DOWN THE MIDDLE AND IN HALF. NO PIECES WERE RETAINED IN THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956131 ↗
• MalfunctionSep 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THE "PORT FELL OFF" FROM THE CATHETER. IT WAS DISCOVERED WHEN THE NURSE WENT INTO THE ROOM. THE CATHETER WAS REPLACED WITH ANOTHER PICC. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478824 ↗
• InjuryJun 4, 2021Fracture

  PT ADMITTED TO ICU. ATTEMPTED PLACEMENT OF PICC TO LEFT UPPER EXTREMITY, BUT PEEL-AWAY SHEATH FRACTURED INSIDE BRACHIAL VEIN. REMOVED BY VASCULAR SURGERY. ARROW REF CDC-45052-VPS2, LOT 23F20H0094, USE BY 2021-10-31, (B)(4). FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11946352 ↗
• MalfunctionMay 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  CUSTOMER REPORTED THE PICC LINE WAS "DIFFICULT TO THREAD THROUGH THE INTRODUCER". A NEW KIT WAS OBTAINED FOR USE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807650 ↗
• MalfunctionMay 6, 2021Material Separation; Material Separation

  CUSTOMER REPORTED "THE INJECTION PORT HAD BEEN SLICED OFF WHERE SIDE CLAMP HAD SECURED PICC LINE LUMEN". IT WAS REPORTED THE CLAMP WAS IN PLACE ON THE LUMEN KEEPING THE SYSTEM CLOSED AND THE PICC LINE WAS REMOVED. NO PATIENT INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11785382 ↗
• MalfunctionMay 5, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: "THE EXTENSION LINE WAS SEVERED VERY CLOSE TO THE INJECTION HUB AND FELL OFF IN HER HAND WHILE THE NURSE WAS APPLYING THE SLIDE CLAMP. THE SLIDE CLAMP WAS USED TO OCCLUDE THE EXTENSION, THE LINE WAS REMOVED AND THEN REPLACED." NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776972 ↗
• MalfunctionApr 19, 2021Fracture; Fracture

  CUSTOMER REPORTED A PICC LINE WAS REMOVED DUE TO THE LINE BEING FRACTURED AND LEAKING. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11690785 ↗
• MalfunctionMar 4, 2021Migration; Migration

  THE COMPLAINT IS REPORTED AS: LINE PLACED ON (B)(6) 2021. PICC LINE PLACED WITHOUT EVENT AND BULLS EYE OBTAINED. PATIENT PROPERLY POSITIONED AT END OF CASE FOR FINAL TIP PLACEMENT/BULLS EYE. XRAY TAKEN ON (B)(6) SHOWED THE LINE IN THE VENTRICLE AND REQUIRING A 4CM PULL BACK. NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417609 ↗

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-3200-2018 · Jul 17, 2018 · Terminated
  5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
• 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