CRE Wireguided 8-10mm 240cm Medical Device Recall Notice
Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that 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 FDA classified this as a Class II recall. The hazard is a potential sterile breach of packaging, which presents a theoretical contamination risk, but no illnesses or injuries are reported in the source text. This fits the Moderate category for FDA Class II recalls without reported adverse health consequences.
Plain-English summary
Boston Scientific Corporation is recalling the CRE Wireguided 8-10mm 240cm medical device due to a potential sterile breach of the pouches in which the devices are packaged. This breach could compromise the sterility of the devices.
A total of 81,543 units have been distributed worldwide, including throughout the US and to numerous countries including Australia, Austria, Canada, China, France, Germany, India, Japan, Mexico, Netherlands, Singapore, South Korea, Spain, and Switzerland, among others.
Affected devices carry UPN M00558460, GTIN 8714729339397, and the following lot numbers: 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, and 38739675, with expiration dates ranging from October 27, 2028 to January 31, 2029.
Healthcare facilities and patients who have these devices should contact Boston Scientific Corporation or consult the FDA for instructions on device disposition and management.
The recalled product
- Product
- CRE Wireguided 8-10mm 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: M00558460
- GTIN: 8714729339397
- Lot No. 38064055
- 38099717
- 38100033
- 38100034
- 38164759
- 38165000
- 38165003
- 38293337
- 38293338
- 38293339
- 38333957
- 38347335
- 38347336
- 38398764
- 38398765
- 38398766
- 38529517
- 38552112
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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