CRE Pro Wireguided medical device sterile packaging breach recall
Boston Scientific Corporation is recalling the CRE Pro Wireguided 10-12mm 240cm device due to potential sterile breach of the pouches in which devices are packaged. The affected product has been 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 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 involving a sterile medical device with compromised packaging integrity. Although no reported illnesses or injuries are stated in the source, the potential for contamination from a sterile breach on an implantable or invasive device poses a risk of harm, placing it in the High category per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling the CRE Pro Wireguided 10-12mm 240cm medical device due to a potential sterile breach of the product pouches. A total of 81,543 units have been distributed worldwide, including across the United States and numerous international markets.
The recall is based on the risk that the sterile packaging may have been compromised, which could affect the sterility of the medical device itself. Affected devices are identified by UPN M00558680 and GTIN 8714729797562, with specific lot numbers ranging from 38031620 through 38959788 and expiration dates between November 23, 2028, and March 29, 2029.
Healthcare facilities and practitioners should quarantine affected units and consult with Boston Scientific Corporation or the FDA for guidance on proper handling, disposal, or replacement. If you have questions, contact the manufacturer or the FDA.
The recalled product
- Product
- CRE Pro 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: M00558680
- GTIN: 8714729797562
- Lot No. 38031620
- 38031621
- 38031622
- 38031623
- 38031624
- 38031625
- 38031626
- 38031627
- 38031628
- 38031629
- 38031631
- 38075353
- 38078357
- 38078358
- 38078359
- 38078740
- 38078741
- 38078742
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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