Boston Scientific Corporation recalls 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. This could result in the embolization of a…
Read the official notice →- Date
- 2024-04-03
- Country
- United States
- Brand
- Boston Scientific
- Product
- Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
- Classification
- Class I
- Units
- Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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FDA · DeviceBoston Scientific CorporationDistribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin…Official notice → - 2023-11-29
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Other drugs & medical recalls in the United States
- 2024-04-03
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Bruder Healthcare Company, LLC recalls Thermalon Stye Compress, Item Number 24352
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Bio-Rad Laboratories recalls Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
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Fresenius Medical Care Holdings, Inc. recalls stay-safe /Luer Lock Adapter 4 in
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