Z-1302-2024Class I
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Boston Scientific Corporation / initiated 2024-02-12 / Open, Classified / root cause: manufacturing process
Boston Scientific Corporation began a recall of Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1302-2024
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
- Product code
- DRA Catheter, Steerable
- 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).
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Recall to its consignees on 02/12/2024 via hand delivery by sales representative. The notice explained the issue, potential risk, and requested the following actions be taken: Immediately cease distribution of the product and "1- Please immediately discontinue use of the Boston Scientific product reported in the list and remove all of the affected units from your inventory, regardless of where these units are stored in your facility. Segregate the units in a secure place, pending return to Boston Scientific. 2- Please complete the attached Verification Form even if you do not have any product to return. 3- When completed, please return the Verification Form to your local Boston Scientific office for the attention of Customer_Service_Fax_Number, on or before 20 February 2024. 4- If you have products to return, please package them in an appropriate shipping box. After receipt of the Verification Form, Boston Scientific will contact you to arrange return. 5- Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred (if appropriate). Please provide Boston Scientific with details of any affected devices that have been transferred to other organizations (if appropriate). If you have any questions or would like assistance with this Field Safety Notice, please contact your local Sales Representative."
- Quantity in commerce
- 461 devices
- Distribution
- Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
- Product codes and lots
- GTIN 08714729992684, Batch Numbers: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1302-2024 | Class I | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.