The Recall Desk
HighFDA (Devices)·Z-1363-2022·Announced 2022-07-20

PALMAZ GENESIS Transhepatic Biliary Stent Risk of Dislodgement

Cordis is recalling 1,089 units of PALMAZ GENESIS Transhepatic Biliary Stents due to potential stent dislodgement in two specific device sizes. Affected patients should contact their healthcare provider.

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: This is an FDA Class II medical device recall involving a risk-of-harm product (potential stent dislodgement in a critical biliary application) where no hospitalizations or injuries have been reported. It meets the 'High' severity threshold as a risk-of-harm product without reported injury.

Plain-English summary

Cordis US Corp is recalling 1,089 units of the PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System. The recall involves catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, and PG3990BPX. These devices carry a potential for stent dislodgement and associated failures related to two specific sizes of the stent.

The affected units were distributed nationwide across all U.S. states and territories, as well as to government and military facilities. Specific lot numbers and expiration dates are available from the FDA recall notice.

Patients who have received these stents should contact their healthcare provider or interventional radiology team immediately to discuss their individual risk and any necessary follow-up care. Healthcare providers should review the recalled lot numbers and contact Cordis for additional information.

The recalled product

Product
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Manufacturer
Cordis US Corp
Category
Medical Device — Biliary Stent
Hazard
  • stent-dislodgement
  • device-malfunction

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 (18)

  • Catalog #PG2990BPS - Lot numbers 82184806
  • exp. 12/31/2022
  • 82191321
  • exp. 3/31/2023
  • and 82208532
  • exp. 10/31/2023. Catalog #PG2990BPX - Lot numbers 82185924
  • exp. 1/31/2023
  • and 82208528
  • exp. 10/31/2023. Catalog #PG3990BPS - Lot numbers 82180267
  • exp. 10/31/2022
  • 82191527
  • 82193089
  • exp. 5/31/2023
  • and 82206059
  • exp. 10/31/2023. Catalog #PG3990BPX - Lot numbers 82208524
  • exp. 11/30/2023
  • and 82211296
  • exp. 12/31/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category