Cordis OPTEASE Retrieval IVC Filter Recall for Labeling Clarification
Cordis Corporation is recalling 33,000 units of the OPTEASE Retrieval IVC Filter to provide additional labeling that minimizes the likelihood of implanting the filter backwards.
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: "Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards."
Plain-English summary
Cordis Corporation is recalling 33,000 units of the Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter, model numbers 466F220A and 466F220B. The recall is a correction intended to provide clarification and additional labeling to minimize the likelihood of implanting the filter backwards.
The affected products were distributed worldwide, including nationwide in the United States and in Canada and Panama. The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism via percutaneous placement in the vena cava in specific clinical situations.
Healthcare providers should refer to the recall notice for specific instructions on how to handle the additional labeling and ensure correct implantation orientation.
The recalled product
- Product
- Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No.…
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — IVC Filter
- Hazard
- Affected units
- 33,000
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 (1)
- Model Numbers 466F220A and 466F220B.
Distribution
Related recalls
Same manufacturer · Cordis Corporation
See all →- HighSMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighSMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighCordis SMART FLEX Biliary Stent System recalled for potential tip separation
FDA (Devices) · 2021-11-24
- HighCordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation
FDA (Devices) · 2021-11-24
- HighFDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk
FDA (Devices) · 2021-11-24
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateCordis Recalls Optease Vena Cava Filter Due to Printing Error
FDA (Devices) · 2013-11-06
- LowCook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates
FDA (Devices) · 2019-03-27
- ModerateCordis ADROIT 6F Guiding Catheter Recalled for Labeling Error
FDA (Devices) · 2013-10-09
- HighVena cava filters recalled over resistance when advancing the dilator
FDA (Devices) · 2025-12-03
- ModerateCordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling
FDA (Devices) · 2012-10-03
- HighCordis Smart Control Vascular Stent Size Mismatch Recalled
FDA (Devices) · 2025-04-09