Porges Coloplast AA6112Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03600040127230), received between Dec 16, 2015 and Nov 13, 2025 — classified as 13 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 reports).

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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Nonstandard Device; Nonstandard Device

  ACCORDING TO THE AVAILABLE INFORMATION THE OPENING IS BEVELED INSTEAD OF BEING ROUNDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544196 ↗
• MalfunctionApr 18, 2025Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN REMOVING THE INDWELLING CATHETER, IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON. THE BALLOON WAS NOT CHECKED BEFOREHAND. CATHETERIZATION WITHOUT PROBLEMS, BUT THERE WAS NO URINE IMMEDIATELY, SO THE DECISION WAS MADE TO INFLATE THE BALLOON WITH 10ML OF WATER TO BE ABLE TO MOBILIZE THE CATHETER. THERE WAS NO PROBLEM INFLATING IT. THE CATHETER WAS IMMEDIATELY REMOVED, BUT THE BALLOON COULD NOT BE DEFLATED, AND THE DECISION WAS MADE TO CUT THE CATHETER. WATER DRAINED SMOOTHLY AND THE CATHETER WAS REMOVED WITHOUT FORCING. THE PATIENT EXPERIENCED NO PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868134 ↗
• InjuryFeb 21, 2025Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION, BALLOON WAS NOT ABLE TO BE EMPTIED WITH 20CC SYRINGES. BALLOON REMAINED IN PLACE FOR ABOUT 10 HOURS AND NEEDED TO BE REMOVED UNDER ULTRASOUND IN THE CONSULTING ROOM OVER A 2-HOUR PERIOD WITH SUBSEQUENT ANTIBIOTIC PROPHYLAXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439863 ↗
• InjuryOct 24, 2024Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN ATTEMPTING TO REMOVE THE CATHETER THE BALLOON WAS UNABLE TO BE DEFLATED WITH A SYRINGE. TO DEFLATE THE BALLOON THE BALLOON WAS PIERCED BY ECHOGRAPHY BY ABDOMINAL PUNCTION. THE PATIENT HAD TO BE SEDATED TO ALLOW BLADDER PUNCTION. THE EXIT FROM THE POST-INTERVENTION ROOM WAS DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521847 ↗
• MalfunctionFeb 20, 2024Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON INFLATED BUT DOES NOT DEFLATE IN THE PATIENT SO THE CATHETER WAS NOT PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743882 ↗
• MalfunctionFeb 14, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION MULTIPLE CATHETER BALLOONS HAVE LEAKED AND A HOLE WAS DETECTED IN THE BALLOON.

  Patient problems: Insufficient Information

  MAUDE report 18703716 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  ACCORDING TO THE AVAILABLE INFORMATION, AFTER FITTING THE BLADDER CATHETER, IT WAS IMPOSSIBLE TO INSTILL THE CHEMOTHERAPY (GEMCITABINE 1G/50ML, 6TH INSTILLATION). THE BLADDER CATHETER WAS REMOVED, AND A PERMEABILITY TEST CARRIED OUT; THE CATHETER WAS NOT PERMEABLE. A NEW CATHETER FROM THE SAME BATCH WAS INSERTED AFTER PERMEABILITY HAD BEEN CHECKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110494 ↗
• MalfunctionAug 1, 2023Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A BURST. DURING TEACHING SESSIONS AT A HOSPITAL, TWO LECTURERS REPORTED PROBLEMS WITH THE BALLOON BURSTING WHEN ONLY PARTIALLY FILLED OR DURING PLACEMENT INTO CATHETERIZATION MODELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17432608 ↗
• MalfunctionJul 31, 2023Material Rupture; Patient Device Interaction Problem; Material Rupture; Patient Device Interaction Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON OF THE FOLYSIL SILICONE CATHETER BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431349 ↗
• MalfunctionDec 6, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE BURST AND FELL OUT DURING USE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928866 ↗
• MalfunctionMar 23, 2022Burst Container or Vessel; Insufficient Device Problem Information; Burst Container or Vessel; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER WAS INSERTED AND THE BALLOON BURST AND THE CATHETER FELL OFF WHEN IT WAS INJECTED WITH WATER (15CC).

  Patient problems: Failure of Implant; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862671 ↗
• InjuryFeb 21, 2022Deflation Problem; Deflation Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS UNABLE TO BE REMOVED FROM THE PATIENT IN A NORMAL FASHION BECAUSE THE BALLOON FAILED TO DEFLATE. IT WAS NOTED THAT THE DOCTOR WAS UNABLE TO REMOVE THE DEVICE BECAUSE IT SEEMED TO BE ADHERED TO THE URINARY MEATUS. A SURGEON WAS ABLE TO REMOVE THE DEVICE WHILE THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 13568480 ↗
• MalfunctionDec 17, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A HAIR IN THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025752 ↗
• 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 12666373 ↗
• 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 12666217 ↗
• 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 12666030 ↗
• InjuryOct 18, 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; Genital Bleeding; Pain

  MAUDE report 12651515 ↗
• InjuryOct 18, 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; Genital Bleeding; Pain

  MAUDE report 12650967 ↗
• InjuryOct 18, 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; Genital Bleeding; Pain

  MAUDE report 12650506 ↗
• MalfunctionJun 10, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST UPON INFLATION WHEN ATTEMPTING TO INSERT CATHETER. IT WAS REPORTED THAT HOSPITAL POLICY AND CATHETER INSTRUCTIONS WERE FOLLOWED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140343 ↗
• InjuryFeb 14, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER BALLOON BURST AND THEN HAD TO BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9714454 ↗
• InjuryFeb 14, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER BALLOON BURSTS AND THEN HAD TO BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9714317 ↗
• InjuryFeb 14, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER BALLOON BURST AND THEN HAD TO BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9714302 ↗
• MalfunctionJul 11, 2017Split

  ACCORDING TO THE AVAILABLE INFORMATION, IT IS SEVERAL TIMES THAT OPERATORS COMPLAIN ON CATHETERS FOLEY AA61 OR CATHETERS AB60: THEY SAY THAT THE ROD SPLITS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6702956 ↗
• MalfunctionJan 31, 2017Obstruction of Flow

  ACCORDING TO THE AVAILABLE INFORMATION, FOLYSIL NELATON CATHETER INSERTED TO PATIENT AND IT WAS NOTICED URINE DID NOT GO THROUGH AT ALL. AFTER TWO HOURS THE CATHETER WAS CHANGED TO NEW ONE WHICH WAS WORKING PROPERLY. THERE MUST BE SOME KIND OF OBSTRUCTION IN THE DRAINAGE CANAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6291043 ↗