Argyle 8888413831Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521004641), received between Apr 23, 2020 and Jul 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 3, 2025Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE INTRODUCER NEEDLE THAT WAS IN THE KIT SNAPPED AT THE NEEDLE WHEN IT WAS BEING INTRODUCED INTO THE PATIENT'S ABDOMEN THROUGH A SURGICAL INCISION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401370 ↗
• MalfunctionApr 23, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE PLACEMENT OF THE INITIAL PD (PERITONEAL DIALYSIS) CATHETER AFTER TUNNELING WAS DONE, THE PHYSICIAN FLUSHED THE PRODUCT AND A LEAK BETWEEN THE CATHETER CUFFS WAS NOTED. IT WAS SAID THAT THE HEALTH CARE PROVIDER (HCP) THEN EXPOSED THE DEVICE FROM THE TUNNEL AND FOUND A HOLE. IT WAS SAID THAT NO CLEANING AGENT WAS USED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. IT WAS HOWEVER REPORTED THAT THE INSERTION SITE WAS TREATED WITH CHLORHEXIDINE TO PREP THE PATIENT'S SKIN PRIORTO PRODUCT PLACEMENT. PRIOR TO USE, IT WAS REPORTED THAT THE PACKAGE WAS STILL SEALED UPON RECEIPT. VISUAL INSPECTION WAS DONE RIGHT AFTER THE PRODUCT WAS TAKEN OUT OF THE PACKAGE AND NO DEFECT OR UNUSUAL OBSERVED WITH THE DEVICE. FLUSHING WAS DONE AND NO ISSUES WERE NOTED. IT WAS ALSO SAID THAT CLAMP WAS NOT USED DURING THE CATHETER INSERTION. THEN DURING THE PLACEMENT OF THE SECOND PD CATHETER (REPLACEMENT), SAME PROCEDURE (FLUSHING, VISUAL INSPECTION AND SKIN PREP) WAS DONE PRIOR TO USE AND WITH NO UNUSUAL RESULTS. IT WAS MENTIONED THAT WHILE THE HCP WAS IN THE PROCESS OF FEEDING THE CATHETER INTO THE GUIDE WIRE THROUGH THE PULL APART SHEATH, THE PRODUCT WAS OBS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989278 ↗
• MalfunctionApr 23, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE PLACEMENT OF THE INITIAL PD (PERITONEAL DIALYSIS) CATHETER AFTER TUNNELING WAS DONE, THE PHYSICIAN FLUSHED THE PRODUCT AND A LEAK BETWEEN THE CATHETER CUFFS WAS NOTED. IT WAS SAID THAT THE HEALTH CARE PROVIDER (HCP) THEN EXPOSED THE DEVICE FROM THE TUNNEL AND FOUND A HOLE. IT WAS SAID THAT NO CLEANING AGENT WAS USED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. IT WAS HOWEVER REPORTED THAT THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THEN DURING THE PLACEMENT OF THE SECOND PD CATHETER (REPLACEMENT), IT WAS MENTIONED THAT WHILE THE HCP WAS IN THE PROCESS OF FEEDING THE CATHETER INTO THE GUIDE WIRE THROUGH THE PULL APART SHEATH, THE PRODUCT WAS OBSERVED TO HAVE BROKEN IN TWO PIECES AT THE BASE OF THE "SUB Q" CUFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989268 ↗