Agency classClass IIOur severity:High FDA (Devices)·Z-1946-2016·Announced 2016-06-22

Cordis PRECISE PRO RX Nitinol Stent System Recalled for Deployment Failure

Cordis Corporation is recalling PRECISE PRO RX Nitinol Stent Systems (Carotid) due to a risk of inability to deploy or partial deployment.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (deployment failure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Cordis Corporation is recalling the PRECISE (R) PRO RX Nitinol Stent System (Carotid) because of a potential defect that may result in the inability to deploy the stent or partial stent deployment. The recall covers 4,400 units in the United States and 3,100 units in foreign countries, including Japan, Taiwan, Thailand, and South Korea.

The affected products are identified by specific catalog numbers and lot numbers, including PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1020RXC, PC1030RXC, and PC1040RXC. The source text does not specify reported illnesses or injuries associated with this defect.

Healthcare providers and patients should check their inventory and patient records for these specific catalog and lot numbers. If a patient has received one of these stents, they should contact their healthcare provider for further evaluation and guidance.

The recalled product

Product: Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Manufacturer: Cordis Corporation
Category: Medical Device — Cardiovascular Stent
Hazard: deployment-failure

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 (20)

Catalog Number: PC0520RXC
Lot Numbers: 17298513
17340803
Catalog Number: PC0530RXC
Lot Numbers: 17283329
17286330
17333401 and 17376719
Catalog Number: PC0540RXC
Lot Numbers: 17295225
17312647
17337070 and 17366679
Catalog Number: PC0620RXC
Lot Numbers: 17256203
17264566
17282136 and 17382573
Catalog Number: PC0630RXC
Lot Numbers: 17255095
17264568
17287132
17294353

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cordis Corporation 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 2 products in this recall →

Same manufacturer · Cordis Corporation

See all →

High
SMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement
FDA (Devices) · 2021-11-24
High
SMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement
FDA (Devices) · 2021-11-24
High
Cordis SMART FLEX Biliary Stent System recalled for potential tip separation
FDA (Devices) · 2021-11-24
High
Cordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation
FDA (Devices) · 2021-11-24
High
FDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk
FDA (Devices) · 2021-11-24

Same hazard · deployment failure