Use caution Medical device recall · FDA · Published February 12, 2024

Boston Scientific POLARSHEATH Steerable Sheath 12F Recall: Risk of Embolization

Boston Scientific recalls POLARSHEATH Steerable Sheath 12F devices with specific batch numbers due to potential inner lumen delamination causing embolization during use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1302-2024Medical device Boston Scientific ›

Use caution until it’s fixed

Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).

Take action

Contact the company

Recalling firmBoston Scientific Corporation4100 Hamline Ave N · Saint Paul, MN 55112-5700

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling a specific model of steerable sheath used in medical procedures. A manufacturing error may cause the sheath to delaminate, potentially leading to embolization of fragments during procedures like flushing or catheter insertion. Read more at govinfonow.com/recall/56171-boston-scientific-polarsheath-steerable-sheath-12f-recall-risk-of-embolization.

Source Summary by GovInfoNow · govinfonow.com/recall/56171-boston-scientific-polarsheath-steerable-sheath-12f-recall-risk-of-embolization · Updated September 23, 2026 · FDA enforcement record: FDA #Z-1302-2024

Cite this page

“Boston Scientific POLARSHEATH Steerable Sheath 12F Recall: Risk of Embolization.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/56171-boston-scientific-polarsheath-steerable-sheath-12f-recall-risk-of-embolization. Based on FDA recall #Z-1302-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1302-2024%22&limit=1).

The FDA announced on Feb. 12, 2024, that Boston Scientific Corporation is voluntarily recalling its POLARSHEATH Steerable Sheath 12F due to a manufacturing error that may cause the shaft to delaminate. The agency issued recall number Z-1302-2024 for the Class I device.

How to tell if you have it

Brand: Boston Scientific
Product: POLARSHEATH Steerable Sheath 12F
REF: M004CRBS3050
UPC: 08714729992684
Batch Numbers: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976

The hazard

A tooling error in manufacturing may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This defect could result in the embolization of a fragment during use, such as when flushing the sheath or introducing a dilator or ablation catheter.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent brand recalls include the Aug. 24, 2026, recall of Imager II Angiographic Catheters for tip fracture risk and the Aug. 6, 2026, recall of LUX-Dx Cardiac Monitor Systems for delayed alerts. Other recent recalls of similar products include the June 26, 2026, Boston Scientific Transcarotid Kit Sheath Depth Markings Recall, the Feb. 13, 2026, Merit Medical BioFlo DuraMax Catheter Recall, and the Dec. 22, 2025, Medline Livewire Steerable Catheters Recall.

How to tell if you have this one

Check the batch numbers on the device: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976. The device is identified by the model number POLARSHEATH Steerable Sheath 12F and reference code M004CRBS3050.

Brand
Boston Scientific
Product
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Batch Number
Look for the batch numbers listed: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976.
Contact Boston Scientific
Reach out to Boston Scientific for further instructions on handling the device if it matches the recalled batch numbers.

How this recall unfolded

Recall timeline

FDA published this recall 51 days after the firm started it.

Feb 12, 2024Firm started the recall
Mar 26, 2024FDA classified it Class I
Apr 3, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56171-boston-scientific-polarsheath-steerable-sheath-12f-recall-risk-of-embolization">Boston Scientific POLARSHEATH Steerable Sheath 12F Recall: Risk of Embolization (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1302-2024 (February 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1302-2024 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.