Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture
Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter 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 is classified as FDA Class II and involves a structural defect (catheter tip fracture) 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 5,020 units of the Neff DAgostino Percutaneous Access Set, Accessories, Catheter. This medical device is intended for single-puncture percutaneous access to facilitate the placement of a working wire guide for interventional radiology procedures. The recall covers all lots, specifically catalog number NPAS-100-DAgostino-B-050393 and global order number G084039. The affected products were distributed nationwide in the United States and internationally to numerous countries.
The recall is being issued due to an increase in reports of polymer degradation at the catheter tip. This degradation can result in the tip fracturing or separating from the device. Such failures can lead to a loss of device function or the separation of a device segment, which may require medical intervention. Complications from separated segments can 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 source text does not specify a recommended action for consumers or healthcare providers, such as stopping use or contacting the manufacturer. Users of this device should refer to the official FDA recall notice for specific instructions on how to handle the recalled product.
The recalled product
- Product
- Neff DAgostino Percutaneous Access 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
- 5,020
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 NPAS-100-DAgostino-B-050393 G08403
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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