PMI PMIORCAP20Recalls & reported problems
Progressive Medical, Inc. · PMI Cholangiogram Combo Pack Includes: Disposable Operative Cholangiogram Catheter 20" and (PMIPIN15) Disposable Percutaneous Introducer 4" length and 14 guage · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812608021529), received between Nov 22, 2023 and Nov 22, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
ON OCTOBER 12TH A LAPAROSCOPIC CHOLANGIOGRAM CATHETER WITH PART NUMBER PMIORCAP20 AND LOT NUMBER 030220401 WAS TAGGED AS DEFECTIVE AFTER THE TIP DISCONNECTED FROM THE CATHETER AS THE SURGEON WAS INSERTING IT IN THE PATIENTS GALLBLADDER FOR DYE INFUSION FOR A CHOLANGIOGRAM. IT WAS NOT REPORTED THAT THE TIP WAS EVER LOOSE INSIDE THE PATIENT. NO HARM TO PATIENT OR COMPLICATIONS WERE REPORTED. NO ADVERSE EVENT WAS REPORTED. THE DEVICE IN QUESTION WAS NOT RETURNED FOR INVESTIGATION. THIS IS THE FIRST PRODUCT PROBLEM WITH PMIORCAP20 LOT NUMBER 030220401. ONLY ONE DEVICE FROM THE LOT OF 200 IS AFFECTED. THERE HAVE BEEN NO SIMILAR REPORTS FOR THIS LOT OR THIS DEVICE AS A WHOLE. PATIENT INFORMATION NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18196256 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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