ROTAWIRE guidewires recalled due to potentially compromised sterile pouch seals
Boston Scientific is recalling ROTAWIRE Drive guidewires due to potentially open pouch seals that could compromise product sterility. Affected units were distributed in the US, territories, Japan, and Canada.
What this means for you
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 FDA Class II recall involves compromised sterile barriers on medical devices. While the hazard represents a potential infection risk, no illnesses or deaths have been reported; therefore, the score is 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling ROTAWIRE Drive and wireClip Torquer, and ROTAWIRE Drive Extra Support guidewires. A total of 488 5-packs were affected by this recall.
The recall was initiated because pouch seals may be open, which compromises the sterility of the products. Maintaining a sterile barrier is essential for medical devices.
The affected devices were distributed to healthcare facilities in the United States and territories, Japan, and Canada. Specific batch numbers and product identifiers have been provided for identification of affected units.
The recalled product
- Product
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Guidewire
- Hazard
- compromised-sterility
- infection-risk
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 (17)
- ROTAWIRE Drive Extra Support
- 5 pack
- UPN: H74939463005 Individual units within 5-pack are labeled as Single
- UPN: H74939463001 Batch numbers: 27630467
- 27632712
- 27701910
- 27705926
- 27749752
- 27749754
- 27792970 27804244
- 27805109
- 27806091
- 27826574
- 27826576
- 27853736
- 27853738
- and 27862767 GTIN: 08714729996231
Distribution
Distribution scope not specified by the agency.
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