Per-Q-Cath Plus Catheter 4235105Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741074981), received between Nov 17, 2017 and Apr 13, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER PERFORATION DURING GUIDEWIRE REMOVAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740521 ↗
• MalfunctionJun 12, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE GUIDEWIRE WAS REMOVED, IT CUT THE CATHETER. ON (B)(6) 2019 - IT WAS REPORTED THAT ONCE THE NURSES OF THE SECTOR IN QUESTION WERE CONTACTED AND THE STATEMENTS WERE MADE, THE PROCEDURE WAS PERFORMED ACCORDING TO THE STANDARDS. MEASUREMENT WAS PERFORMED, THE GUIDEWIRE WAS RETRACTED BEFORE CUTTING THE CATHETER IN DIMENSIONED MEASUREMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8692819 ↗
• MalfunctionJun 11, 2019Break

  IT WAS REPORTED THAT THE INTRODUCER PRESENTED BREAK WITH ONLY ONE USE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689168 ↗
• MalfunctionJun 11, 2019Break

  IT WAS REPORTED THAT THE INTRODUCER AFTER A SINGLE PUNCTURE WAS LEFT WITH THE DAMAGED END. ON (B)(6) 2019 - IT WAS REPORTED THAT THE NURSES MENTIONED THAT THE TIP OF THE INTRODUCER WAS DAMAGED IMMEDIATELY AFTER THE FIRST PUNCTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689164 ↗
• MalfunctionJun 28, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PICC PASSAGE, SOME TESTS WERE PERFORMED AND IT DIDN'T PRESENT FLUX OR RETURN WHEN INFUSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648991 ↗
• MalfunctionMar 7, 2018Material Rupture

  IT WAS REPORTED THAT AN ADULT PATIENT WAS PUNCTURED WITH A PICC CATHETER, ON (B)(6) 2018. THE PROCEDURE OCURRED WITHOUT INTERCURRENCE, AT THE END IT WAS DONE SALINIZATION OF THE CATHETER WITH A 10 ML SYRINGE AND THEN THE CATHETER RUPTURED NEXT TO THE "FIXATION BUTTERFLY", AND BECAUSE OF THAT IT WAS NECESSARY TO WITHDRAWAL THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7322279 ↗
• MalfunctionNov 17, 2017Break

  IT WAS REPORTED THAT ACCORDING TO THE NURSE, AFTER POSITIONING, THE CATHETER BROKE DURING USE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7042676 ↗