Porges Coloplast AA6122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03600040127865), received between Oct 19, 2021 and May 6, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 2, 2024Class IIOpen, Classified

   A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

   Z-0844-2025 · Root cause: Packaging · Recall details · FDA record ↗

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.

• MalfunctionMay 6, 2025Material Separation; Material Separation

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE PACKAGING WAS OPENED THE PHARMACIST SAW THAT THE TIP OF THE CATHETER WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971084 ↗
• InjuryOct 20, 2021Difficult to Advance; Difficult to Advance

  ACCORDING TO THE AVAILABLE INFORMATION, DURING LOADING OF THE GUIDEWIRE, THE GUIDE WIRE DIDN'T SLIDE IN THE CATHETER, THUS THE GUIDE WIRE LOOPED IN THE EXTREMITY AND NEVER GOT OUT. THE REPLACEMENT OF THE CATHETER ASSISTED BY GUIDEWIRE CAN'T BE DONE AND FINISHED WITHOUT IT. CLINICAL CONSEQUENCES: USE OF CYSTOCATH, SO HEAVY PAIN AND MOBILIZATION OF MEDICAL AND PARAMEDICAL STAFF, ULTRASOUND, ANESTHETIC GAS, ETC. IT WAS NOTED "USE OF A LOT OF XYLOCAINE GEL," AND THAT THE CAUSE OF THE EVENT WAS THE PRODUCT.

  Patient problems: Pain

  MAUDE report 12668615 ↗
• InjuryOct 19, 2021Deflation Problem; Deflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON DID NOT FULLY DEFLATE DURING WITHDRAWAL AND CREATED A PLEATED BULGE THAT INCREASED THE DIAMETER AND "CREATED SOME RELIEF." THE PATIENT EXPERIENCED PAIN DURING WITHDRAWAL "LINKED BY THE GRIP" AND BLEEDING OF THE "INTERNAL HOLE." TRIGGERING OF AUTONOMIC HYPER REFLEXIA WAS ALSO REPORTED. IT WAS NOTED "USE OF A LOT OF XYLOCAINE GEL" AND THAT THE CAUSE OF THE EVENT WAS THE PRODUCT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 12656958 ↗