The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2557-2014·Announced 2014-09-03

Cordis EMPIRA RX PTCA Dilatation Catheter Recalled for Balloon Cover Removal Issues

Cordis Corporation is recalling EMPIRA RX PTCA Dilatation Catheters because the balloon cover may be difficult to remove, potentially causing balloon burst or shaft separation during use.

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 involves a medical device with a risk of harm (vessel trauma, surgery) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Cordis Corporation is recalling the EMPIRA RX PTCA Dilatation Catheter. The recall involves 250,000 units distributed worldwide, including the United States, Puerto Rico, and several countries in the Americas. The affected products are identified by 70 specific catalog numbers listed in the recall notice.

The recall is due to a defect where the balloon may exhibit resistance to the removal of the balloon cover. If excessive force is applied to remove the cover, the product may weaken in the region of the proximal balloon seal. This weakening can lead to balloon burst, shaft separation, or deflation difficulties.

These mechanical failures could result in procedural delay, vessel trauma, or the need for surgery. The source text does not report any specific illnesses, injuries, or fatalities associated with this defect. Consumers and healthcare providers should stop using the affected catheters and contact Cordis Corporation for further instructions.

The recalled product

Product
Cordis EMPIRA RX PTCA Dilatation Catheter
Manufacturer
Cordis Corporation
Category
Medical Device — Cardiovascular Catheter
Hazard
Affected units
250,000

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)

  • 70 Catalog numbers: 85R06150S
  • 85R06200S
  • 85R06225S
  • 85R06250S
  • 85R06275S
  • 85R06300S
  • 85R06325S
  • 85R06350S
  • 85R06375S
  • 85R06400S
  • 85R10150S
  • 85R10200S
  • 85R10225S
  • 85R10250S
  • 85R10275S
  • 85R10300S
  • 85R10325S
  • 85R10350S
  • 85R10375S
  • 85R10400S

Distribution

Distributed in 40 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 →

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