CRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may 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: This is an FDA Class II recall. The source text identifies only a potential sterile breach of packaging with no reported illnesses or injuries, making it a precautionary/low-risk contamination scenario that falls under the Moderate category.
Plain-English summary
Boston Scientific Corporation is recalling the CRE Pro Wireguided 15-18mm 240cm medical device worldwide, including distribution in the United States and numerous international markets. The reason for the recall is a potential sterile breach of the pouches in which the devices are packaged.
The affected devices were distributed with specific lot numbers between November 24, 2028, and March 26, 2029. A total of 81,543 units were distributed. The product UPN is M00558700 and the GTIN is 8714729797586.
If you have received this device, contact Boston Scientific Corporation for instructions regarding the recalled product. Do not use any units from the affected lot numbers listed in the FDA notification.
The recalled product
- Product
- CRE Pro 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: M00558700
- GTIN: 8714729797586
- Lot No. 38043116
- 38192116
- 38192117
- 38192118
- 38192119
- 38192960
- 38192961
- 38214896
- 38214897
- 38222153
- 38222496
- 38222497
- 38222498
- 38222499
- 38222660
- 38222661
- 38222662
- 38222663
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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