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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The issue is a labeling clarification to prevent incorrect implantation orientation.
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. S
- 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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02