PMI PMIORCBRecalls & reported problems

Progressive Medical, Inc. · PMI Disposable Cholangiograph Catheter 7", for traditional open procedure · Class 1

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812608021017), received between Jul 30, 2025 and Jul 30, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Split, Cut or Torn1

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.

InjuryJul 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
DURING A LAP CHOLE, [THE SURGEON] INSERTED A CHOLANGIOGRAM CATHETER (PMIORCB) THROUGH A SMALL INCISION IN THE ABDOMEN. [THE SURGEON] IS A GENERAL SURGEON WITH MULTIPLE YEARS OF EXPERIENCE WITH THE PROCEDURE AND WITH PMIORCB. DURING INSERTION OF THE CATHETER, THE TIP/BEND OF THE PRODUCT BROKE OFF. THIS PORTION OF THE CATHETER REMAINED IN THE PATIENT'S SUBCUTANEOUS TISSUE IN THE RIGHT UPPER QUADRANT OF THE ABDOMEN. THE BROKEN PORTION WAS LOCATED USING X-RAY IMAGING AND REMOVED. [THE SURGEON] WAS ABLE TO ENLARGE THE INCISION AND COMPLETELY REMOVE THE CATHETER TIP THAT HAD BROKEN OFF. THE PATIENT'S CLINICAL OUTCOME WAS REPORTEDLY "GOOD." THE SURGERY TIME WAS EXTENDED, BUT THE PATIENT EXPERIENCED NO COMPLICATIONS POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666723 ↗

Device details

UDI-DI	`00812608021017`
Brand	PMI
Model	PMIORCB
Company	Progressive Medical, Inc.
Product code	GBZ · Catheter, Cholangiography
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 10, 2022

Device type (GMDN): Interventional radiology percutaneous-access kit, single-use

A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.