CRE Wireguided Device Recall Due to Potential Sterile Packaging Breach
Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices due to a potential sterile breach in the pouches containing the devices. The breach could compromise device sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses or injuries, and the hazard is a potential sterile breach—a precautionary concern rather than confirmed contamination. This meets the rubric criterion for a moderate-severity voluntary precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices worldwide. The recall is due to a potential sterile breach of the pouches in which the devices are packaged.
A compromise of sterile packaging could lead to contamination of the device prior to use. Healthcare providers and patients who have received affected units should contact Boston Scientific Corporation for instructions on return and replacement.
The affected devices were distributed worldwide, including throughout the United States and in numerous countries internationally. Affected lot numbers include 38033567, 38056239, 38056940, 38056941, 38215260, 38266854, 38266855, 38293330, 38391881, 38413876, 38413877, 38413878, 38413879, 38414080, 38422547, 38446204, 38466097, 38468862, 38468863, 38529518, 38529519, 38585004, 38622477, 38622478, 38640994, 38670501, 38670502, 38670504, 38686282, 38686283, 38693725, 38726666, 38726667, 38748254, 38767487, 38789996, 38800181, 38879160, 38879163, 38879164, 38911928, 38911929, 38911930, and 38944841, with expiration dates between October 24, 2028 and February 24, 2029.
The recalled product
- Product
- CRE Wireguided 12-15mm 240cm
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 81,543
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UPN: M00558480
- GTIN: 8714729339410
- Lot No. 38033567
- 38056239
- 38056940
- 38056941
- 38215260
- 38266854
- 38266855
- 38293330
- 38391881
- 38413876
- 38413877
- 38413878
- 38413879
- 38414080
- 38422547
- 38446204
- 38466097
- 38468862
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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