Cordis recalls specific PALMAZ Genesis Transhepatic Biliary Stent models due to potential dislodgement. Affected units have catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX with listed lot numbers and expiration dates.
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Cordis is recalling certain PALMAZ Genesis Transhepatic Biliary Stents on OPTA PRO delivery systems because they may dislodge, causing serious complications. This recall affects specific catalog numbers with particular lot numbers and expiration dates.
The stents may dislodge during medical procedures, leading to potential blockages or complications in the bile ducts. This risk is associated with specific device sizes and manufacturing lots.
Medical professionals using the recalled stents for liver procedures are most at risk. Patients who have received these stents should consult their healthcare provider.
Check for catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, or PG3990BPX on the device packaging. Verify the lot numbers and expiration dates listed in the recall notice.
Review the catalog number and lot numbers on the stent packaging to confirm if it is affected.
The recall affects PALMAZ Genesis Transhepatic Biliary Stents with catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, and PG3990BPX.
Check the catalog number and lot numbers on the packaging; affected units have specific lot numbers and expiration dates listed in the recall notice.
Contact your healthcare provider to discuss next steps, as the recall does not specify a return or repair process.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1363-2022 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1363-2022 from Cordis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.