CRE Pro Wireguided Boston Scientific Recall
CRE Pro Wireguided 12-15mm 240cm
Updated May 21, 2026
Boston Scientific's CRE Pro Wireguided devices (12-15mm, 240cm) have a potential sterile packaging breach. If the pouch was damaged or unsealed, the device could be contaminated and unsafe to use.
Is the Boston Scientific Corporation recalled? Yes. This product was recalled by FDA on May 21, 2026. Details below.
What is recalled
CRE Pro Wireguided 12-15mm 240cm devices manufactured by Boston Scientific Corporation
Am I affected
You are affected if you have a CRE Pro Wireguided device in 12-15mm size and 240cm length with compromised or questionable packaging integrity.
What to do right now
Stop using any CRE Pro Wireguided device with damaged or unsealed packaging. Contact Boston Scientific Corporation or the facility where you obtained the device to report the issue and determine next steps.
The hazard
Potential sterile breach of the pouches in which devices are packaged.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2629-2026
- Classification
- Class II
- Recalled
- May 21, 2026
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