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primePICC PFM2CT5DLRecalls & reported problems

Pfm Medical Incorporated · 5F (1.67mm) x 55cm DUAL LUMEN CT PICC OTW KIT · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813623013735), received between Aug 9, 2021 and Sep 22, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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

Device problems

  • Crack5

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Bacterial Infection1
  • Failure of Implant1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 22, 2021Crack; Crack

    PICC LUER HUB CRACKED. THERE WAS NO INJURY NOTED TO THE PATIENT. THE PICC CATHETER WAS REMOVED. AT THIS POINT, A PERIPHERAL CATHETER WAS PLACED AND WE WILL CONTINUE TO DETERMINE IF CENTRAL ACCESS IS/IS NOT NECESSARY.

    Patient problems: Failure of Implant

    MAUDE report 12512593 ↗
  • MalfunctionAug 9, 2021Crack; Crack

    LUER HUB CRACKED DURING USE. NURSE USED FORCEPTS. PICC WAS REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12297534 ↗
  • MalfunctionAug 9, 2021Crack; Crack

    LUER HUB CRACKED DURING USE. NURSE USED FORCEPTS. PICC WAS REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12297520 ↗
  • MalfunctionAug 9, 2021Crack; Crack

    LUER HUB CRACKED DURING USE. NURSE USED FORCEPTS. PICC WAS REPLACED. BLOOD CULTURES FROM (B)(6) 2021 WERE POSITIVE FOR BACTERIA GROWTH.

    Patient problems: Bacterial Infection

    MAUDE report 12297519 ↗
  • MalfunctionAug 9, 2021Crack; Crack

    LUER HUB CRACKED DURING USE. NURSE USED FORCEPTS. PICC WAS REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12297294 ↗

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-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
  • 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

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Sources and updates

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