CRE Wireguided 15-18mm 240cm Medical Device Sterile Pouch Breach
Boston Scientific Corporation is recalling the CRE Wireguided 15-18mm 240cm device due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide.
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: This is an FDA Class II recall involving a potential sterile breach in device packaging. The source text does not report any illnesses or injuries; the hazard is theoretical—a packaging defect that could compromise sterility. Per the rubric, Class II recalls without reported hospitalization or adverse health consequences default to Moderate (score 2).
Plain-English summary
Boston Scientific Corporation is recalling the CRE Wireguided 15-18mm 240cm medical device. The recall is due to a potential sterile breach of the pouches in which the devices are packaged.
This recall affects 81,543 units distributed nationwide in the United States and internationally to Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, Türkiye, United Arab Emirates, and Uruguay.
Affected lot numbers include 38033568, 38033569, 38033570, 38033571, 38047498, 38047722, 38047731, 38200167, 38239090, 38325015, 38325016, 38325017, 38413205, 38413206, 38413207, 38413208, 38413214, 38422540, 38422541, 38422542, 38422543, 38479759, 38507303, 38507304, 38519497, 38519498, 38529540, 38529541, 38529542, 38529543, 38529544, 38585005, 38585006, 38647771, 38790079, 38817673, 38817674, 38817675, 38817676, 38817677, 38817678, and 38817679, with expiration dates ranging from October 24, 2028 to February 9, 2029. Patients and healthcare providers who have this device should contact Boston Scientific Corporation or consult the FDA website for instructions on how to proceed.
The recalled product
- Product
- CRE Wireguided 15-18mm 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: M00558490
- GTIN: 8714729339427
- Lot No. 38033568
- 38033569
- 38033570
- 38033571
- 38047498
- 38047722
- 38047731
- 38200167
- 38239090
- 38325015
- 38325016
- 38325017
- 38413205
- 38413206
- 38413207
- 38413208
- 38413214
- 38422540
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.
See all 12 products in this recall →Related recalls
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