PICC Prime PFM2CT5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813623013728), received between Sep 14, 2018 and Feb 6, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K083873); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PICC CRACKED AND LEAKING. REPLACED ON (B)(6) 2016.

  Patient problems: No Information

  MAUDE report 8313061 ↗
• InjurySep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ISSUE WITH A GUIDE WIRE IN WHICH RESULTED IN THE PATIENT HAVING TO BE SENT TO IR FOR REMOVAL. AFTER OBTAINING ACCESS TO THE VEIN WITHOUT ISSUE, THE GUIDEWIRE WAS INSERTED. THE GUIDEWIRE WAS ONLY ABLE TO BE INSERTED 6-10 CM IN. AN ATTEMPT TO REMOVE THE GUIDEWIRE WAS MADE BUT WAS NOT SUCCESSFUL. THE NEEDLE WAS REMOVED AND A SECOND ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE PULING THE LINE GENTLY, HOWEVER IT BEGAN TO FRAY AND COME UNRAVELED. THE ULTRASOUND WAS USED TO VISUALIZE THE GUIDEWIRE AND SHOWED IT INSIDE THE VESSEL BUT APPEARED TO HAVE DEVELOPED A KNOT AT THE END. AN INCISION WAS CREATED AND THE INTRODUCER INSERTED TO TRY TO CREATE A LARGER OPENING FOR THE GUIDEWIRE. THIS WAS UNSUCCESSFUL. THE WIRE WAS THEN COILED, THE INSERTION SITE DRESSED, AND THE MD WAS NOTIFIED.

  Patient problems: Discomfort; Vessel Or Plaque, Device Embedded In

  MAUDE report 7878827 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083873. One submission often covers many models, so check the product and lot details in each record.

• Z-0565-2015 · Oct 20, 2014 · Terminated
  ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated f
• Z-0564-2015 · Oct 20, 2014 · Terminated
  6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intra
• Z-0563-2015 · Oct 20, 2014 · Terminated
  Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The