The Recall Desk
HighFDA (Devices)·Z-1947-2016·Announced 2016-06-22

Cordis PRECISE RX Nitinol Stent System Recalled for Deployment Failure

Cordis Corporation is recalling PRECISE RX Nitinol Stent Systems (Biliary) due to the inability to deploy the stent or partial deployment.

What this means for you

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. The hazard involves a functional failure (inability to deploy) of a medical device, which poses a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cordis Corporation is recalling the PRECISE (R) RX Nitinol Stent System (Biliary) because of a defect that can result in the inability to deploy the stent or partial stent deployment. The recall covers specific catalog and lot numbers, including P05030RXB, P09030RXB, P07030RXB, P07040RXB, and P06040RXB.

Approximately 4,400 units were distributed in the United States and 3,100 units were shipped to foreign countries, including Japan, Taiwan, Thailand, and South Korea. The affected devices are biliary stents used in medical procedures.

Healthcare providers and facilities should stop using the affected stent systems and contact Cordis Corporation for further instructions on handling the recalled units.

The recalled product

Product
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Manufacturer
Cordis Corporation
Category
Medical Device — Stent
Hazard

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 (10)

  • Catalog Number: P05030RXB
  • Lot Number: 17241836
  • Catalog Number: P09030RXB
  • Lot Number: 17241838
  • Catalog Number: P07030RXB
  • Lot Number : 17291878
  • Catalog Number: P07040RXB
  • Lot Number: 17291879
  • Catalog Number: P06040RXB
  • Lot Number: 17415243.

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 →

Related recalls

Same manufacturer · Cordis Corporation

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Same hazard · deployment failure

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