Boston Scientific POLARSHEATH Steerable Sheath 12F recall
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Why was Boston Scientific POLARSHEATH Steerable Sheath 12F 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 461 devices
- Distribution
- Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
- Recall date
- April 3, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)