Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported April 3, 2024
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
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. Thi…
Boston Scientific Corporation recalled Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 - a critical-severity action.
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 was recalled by Boston Scientific Corporation in April 3, 2024. Reason: Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the i…. Check the official notice for the remedy. Verify recall #Z-1302-2024 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this critical-severity FDA Devices recall-Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the i….
- Critical
- severity level
- 461 units
- affected scope
- Class I
- classification
- April 3, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1302-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1302-2024) was formally reported on April 3, 2024, with the manufacturer initiating the action on February 12, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Boston Scientific Corporation is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 461 devices.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
461 devices
Related Recalls
6
3 from same agency
Product description
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Reason for recall
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1302-2024 |
| Date reported | April 3, 2024 |
| Date initiated | February 12, 2024 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Saint Paul, MN |
| Affected scope | 461 devices |
| Distribution | Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1302-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050. Recalled by Boston Scientific Corporation. Units affected: 461 devices.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2024. Severity: Critical. Recall number: Z-1302-2024.
Where was the recalled product distributed? ▼
Distribution: Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1302-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 3, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.