CRE Pro Wireguided 8-10mm 240cm Medical Device Sterile Pouch Breach
Boston Scientific is recalling CRE Pro Wireguided 8-10mm 240cm devices worldwide due to a potential sterile breach of the product packaging pouches. The breach could compromise the sterility of the devices.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile medical device with a potential sterile breach that could lead to infection risk. The source text does not report any illnesses or injuries, making the hazard theoretical. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling the CRE Pro Wireguided 8-10mm 240cm medical device due to a potential sterile breach of the pouches in which the devices are packaged. Approximately 81,543 units have been distributed worldwide, including across the United States and to numerous countries including Canada, Australia, Japan, Mexico, and many others.
A compromised sterile pouch may allow the device to become non-sterile, which could increase the risk of infection or other complications if the device is used. Consumers and healthcare providers should stop use of affected units from the recalled lot numbers and contact Boston Scientific for further instructions.
Affected lot numbers are: 38031497, 38031499, 38067106, 38067107, 38067108, 38075352, 38077694, 38078752, 38078753, 38078754, 38078756, 38110982, 38131542, 38131543, 38131544, 38162876, 38169207, 38174433, 38176724, 38176725, 38176728, 38176729, 38200576, 38200577, 38212061, 38240328, 38285224, 38297438, 38297439, 38297800, 38297801, 38306683, 38306684, 38357962, 38357963, 38357964, 38357965, 38357966, 38357967, 38371552, 38381888, 38398493, 38400165, 38437963, 38468757, 38468758, 38468861, 38507306, 38507307, 38552610, 38552611, 38552612, 38552613, 38568865, 38568866, 38568867, 38579282, 38579283, 38591247, 38598328, 38598329, 38598330, 38622433, 38622434, 38622435, 38650822, 38690511, 38690512, 38697220, 38697221, 38747993, 38747994, 38770143, 38770144, 38770145, 38770146, 38770147, 38770148, 38770149, 38770150, 38886485, 38886486, 38886487, 38934882, 38958333, 38960098, 38960099, 38970337, with expiration dates ranging from November 23, 2028 through March 30, 2029.
The recalled product
- Product
- CRE Pro 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: M00558670
- GTIN: 8714729797555
- Lot No. 38031497
- 38031499
- 38067106
- 38067107
- 38067108
- 38075352
- 38077694
- 38078752
- 38078753
- 38078754
- 38078756
- 38110982
- 38131542
- 38131543
- 38131544
- 38162876
- 38169207
- 38174433
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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