Agency classClass IOur severity:Severe FDA (Devices)·Z-1257-2021·Announced 2021-03-24

Cordis Precise Pro RX Carotid Stent Recall for Tip Separation

Cordis is recalling Precise Pro RX Carotid Stent implant systems because the distal tip may separate from the lumen wire.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Distal tip may become separated from the lumen wire in specific lots."

Plain-English summary

Cordis Corporation is recalling the Precise Pro RX Carotid Stent implant system. The recall involves 18,218 units distributed in the United States (excluding Montana and New Mexico) and Taiwan.

The recall was initiated because the distal tip of the stent may become separated from the lumen wire in specific lots. The affected product codes and lot numbers are detailed in the official recall documentation.

Healthcare providers and patients who have received these specific stent systems should contact Cordis Corporation for further instructions on the recall and potential replacement or repair options.

The recalled product

Product: PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
Manufacturer: Cordis Corporation
Category: Medical Device — Cardiovascular Stent
Hazard: structural-defect
component-separation
Affected units: 18,218

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)

1. PC0520RXC
Lot Numbers: 17917082
17925698
17945241
17946961 2. PC0530RXC
Lot Numbers: 17907242
17915157
17931757
17936915
17940306
17945490
17950283
17952939 3. PC0540RXC
Lot Numbers: 17907243
17911879
17920422
17931758
17942800
17945242
17947078

Distribution

Distributed in 2 states:

Same manufacturer · Cordis Corporation

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Cordis SMART FLEX Biliary Stent System recalled for potential tip separation
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Cordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation
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FDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk
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Same hazard · structural defect