Boston Scientific CRE Wireguided Medical Device Recall Sterile Breach
Boston Scientific is recalling CRE Wireguided 10-12mm 240cm medical devices due to a potential sterile breach in the product packaging. The breach could compromise device sterility and affect patient safety.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. A sterile breach of medical device packaging is a significant manufacturing defect that directly threatens patient safety by compromising device sterility, meeting the criteria for a Severe rating.
Plain-English summary
Boston Scientific Corporation is recalling the CRE Wireguided 10-12mm 240cm medical device due to a potential sterile breach in the pouches used to package the devices. The sterile breach could compromise the sterility of the affected units.
The recall affects 81,543 units worldwide. Affected products include specific lot numbers from 38099718 through 38937571, with expiration dates ranging from November 2, 2028 to February 23, 2029. The devices have been distributed across the United States and internationally to countries including Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, and many others.
Healthcare facilities and patients who have received these devices should contact Boston Scientific Corporation immediately for instructions on device replacement or further guidance. Physicians should review whether patients have received affected devices and follow appropriate clinical protocols.
The recalled product
- Product
- CRE Wireguided 10-12mm 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: M00558470
- GTIN: 8714729339403
- Lot No. 38099718
- 38165001
- 38165002
- 38196568
- 38196569
- 38196570
- 38204511
- 38204512
- 38204513
- 38285933
- 38397792
- 38398767
- 38398768
- 38507308
- 38552115
- 38596881
- 38596882
- 38612829
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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