PR Product Recall Checker
FDA product recall ยท Z-2755-2026

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062 Recall Details

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

Medical Device High risk Jul 29, 2026

Confirm With The Official Notice

Use this page to screen for a possible match. Use the linked official notice before you stop use, throw away, return, repair or schedule service.

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Recall overview

What This Recall Notice Says

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

Read Official Notice
Before you act: a similar product name is not enough. Match the identifiers, affected dates, model or lot details, and remedy instructions in the official notice.
1. Match the item

Check device name, UDI, model, lot, serial and software version.

2. Read the risk

Review the hazard, consequence, risk level and whether the notice says to stop using, stop eating or keep the item away from children.

3. Follow the remedy

Look for refund, repair, replacement, disposal, software update, dealer service or company contact instructions.

4. Verify officially

Open the official source before making a safety decision, especially for vehicles, food, baby products and medical devices.

How To Tell If Yours Is Included

Device recalls can depend on UDI, model, catalog number, lot, serial number, software version or implant card details. Match the label before changing device use.

Recall Hazard And Risk

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

Recall Remedy

Use the official notice for remedy instructions. Product recall remedies may include repair, replacement, refund, disposal, software update, dealer service or a stop-use instruction.

Affected Product Or Item

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062

Hazard Or Reason For Recall

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

How To Check If This Recall Applies To You

Match The Device Label

Compare UDI, product code, model, catalog number, lot, serial number and software version before changing device use.

Compare Codes And Date Ranges

Check UPCs, lot codes, serial numbers, model numbers, best-by dates, date codes, VIN ranges, production dates or official campaign numbers when available.

Read The Hazard Before Use

Hazards can involve injury, fire, choking, contamination, undeclared allergens, crash risk, device failure, electrical shock or incorrect labeling.

Follow The Official Remedy

Confirm final instructions in the linked official notice before returning, repairing, disposing, stopping use, stopping consumption, contacting the company or scheduling service.

Key Medical Device Recall Checks

Use these checks to decide whether the notice is relevant to the item you have, then confirm with the official source.
Identity

UDI, Model, Lot And Serial

Medical device recalls can depend on UDI, product code, software version, model, lot or serial number.

Risk

Hazard, Consequence And Risk Level

Use the hazard, consequence and risk level to understand whether the product should be stopped immediately or handled through normal recall instructions.

Action

Repair, Replacement, Refund Or Disposal

Recall remedies differ by agency and product type. The official notice is the final source for repair, refund, replacement, disposal, dealer service or stop-use steps.

Source

Official Agency Notice

This page helps you review public recall details in one place. Always use the linked agency or company notice before making a safety decision.

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Recall Detail FAQ

Short answers for checking whether this recall notice applies to your item.

How do I know if this recall affects my product?

Compare the product name, brand, model, UPC, lot code, serial number, VIN, date code, package size, retailer and distribution details with the official notice. All key details should match.

What should I do after finding a matching recall?

Stop using, feeding, driving or consuming the product when the notice says to do so, then follow the official remedy for repair, replacement, refund, disposal, service or company contact.

Is this page the official recall notice?

No. This site helps you review public recall details. Use the linked official notice as the final source for affected products and safety instructions.

Why can a recall page change after publication?

Agencies and companies may update notices with expanded products, corrected codes, new risk classifications, remedy availability or additional distribution details.