Agency classClass IIOur severity:Severe FDA (Devices)·Z-2617-2016·Announced 2016-08-31

Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk

Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a structural defect (tip fracture/separation) that can lead to significant injury, such as embolization to the heart or lungs or occlusion of blood flow, meeting the criteria for a Severe rating.

Plain-English summary

Cook Inc. is recalling 26,076 units of the Kumpe Access Catheter, a ureteral catheter used in general and plastic surgery. The device is used in combination with a flexible-tipped wire guide to gain difficult ureteral access beyond redundant or tortuous segments. The recall covers all lots, specifically catalog/product number 023565-BT and global/order number G18074.

The recall is due to an increase in reports of polymer degradation of the catheter tip, which can result in tip fracture and/or separation. This degradation can lead to loss of device function or the separation of a device segment, which may require medical intervention. Complications from separated segments can include device fragments remaining in the vascular system, genitourinary system, or other soft tissues.

Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs. The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Healthcare providers and patients should stop using the affected devices and contact Cook Inc. for further instructions.

The recalled product

Product: Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
Manufacturer: Cook Inc.
Category: Medical Device — Ureteral Catheter
Hazard: device-fracture
embolization
vascular-occlusion
Affected units: 26,076

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

All Lots. Catalog/product number
Global/order number 023565-BT G18074

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Same manufacturer · Cook Inc.

See all →

High
Skinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
High
Cook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
Moderate
Flexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
High
Transseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
High
Transseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24

Same hazard · device fracture