ACUCISE® PROCEDURAL PACK UNIVERSAL PACK A BK002Recalls & reported problems

Applied Medical Resources Corporation · Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3301, STENT, C-FLEX, 7/10F X 26CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX · Class 2

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 20607915128122), received between Feb 1, 2016 and Feb 1, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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.

Most reported problems

Device problems

Inflation Problem1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 1, 2016Inflation Problem; Inflation Problem
ACUCSIE ENDOPYELOTOMY - "DR. (B)(6) PERFORMED THE PROCEDURE. THE BALLOON DID NOT STAY INFLATED FOLLOWING ACTIVATION OF THE CUTTING WIRE. WIRE WAS ACTIVATED FOR 5 SECONDS AT 75W PURE CUT. DEVICE WAS OBSERVED TO HOLD INFLATION FOR CUTTING STEP OF PROCEDURE, BUT WHEN FLUOROSCOPY WAS PERFORMED MINUTES AFTER, NO CONTRAST SOLUTION REMAINED IN THE BALLOON. UPON REMOVAL OF DEVICE, DAMAGE TO THE BALLOON WAS OBSERVED. AFTER REMOVAL OF THE DEVICE, A 2CC SYRINGE OF STERILE WATER WAS INJECTED INTO THE BALLOON INFLATION PORT AND LEAKAGE WAS CONFIRMED. THIS B1005 WAS PART OF THE BK002 KIT LOT 1248705." PATIENT STATUS - "NA."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5402510 ↗

Device details

UDI-DI	`20607915128122`
Brand	ACUCISE® PROCEDURAL PACK UNIVERSAL PACK A
Model	BK002
Company	Applied Medical Resources Corporation
Product code	KNY · Accessories, Catheter, G-U
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 23, 2024

Device type (GMDN): Ureteral stent-placement set

A collection of devices used to facilitate the implantation of a ureteral stent, via the natural orifice or percutaneously through a tortuous ureter, in order to maintain ureteral patency. The devices are typically made of high-grade stainless steel and/or a polymer [e.g., polyvinyl chloride (PVC)] and typically include a guidewire, a dilator, a positioner, an inserter, a placement catheter, an introduction sheath, and a release sleeve. Some of the devices may be radiopaque, and may have Luer connectors at the proximal end to allow for the injection of a contrast medium. 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.