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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- 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
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.
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