The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2620-2016·Announced 2016-08-31

Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture

Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.

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 is classified as FDA Class II and involves a structural defect (tip fracture/separation) that can lead to significant injury, such as embolization or occlusion of blood flow, meeting the criteria for a Severe rating.

Plain-English summary

Cook Inc. is recalling 148,334 units of Aprima Access Nonvascular Introducer Sets. These medical devices are intended for single-puncture percutaneous access to facilitate the placement of a working wire guide during interventional radiology procedures. The recall covers all lots and includes various catalog numbers beginning with NPAS- and NSSW-.

The recall is being conducted due to an increase in reports of polymer degradation at the catheter tip, which can result in tip fracture or separation. This degradation may lead to a loss of device function or the separation of a device segment, which could require medical intervention. Complications from separated segments include fragments remaining in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could potentially result in embolization to the heart or lungs or occlude blood flow to end organs.

The affected products were distributed worldwide, including nationwide in the United States and to numerous international locations. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it state if any specific injuries or illnesses have been reported.

The recalled product

Product
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Manufacturer
Cook Inc.
Category
Medical Device — Interventional Radiology
Hazard
Affected units
148,334

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 (1)

  • All Lots. Catalog prefixes / suffixes NPAS-/-SST Catalog/product number

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 →

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