Boston Scientific ROTAWIRE Drive guide wire devices recalled for open pouch seals
Boston Scientific is recalling ROTAWIRE Drive and ROTAWIRE Drive Floppy guide wire devices because pouch seals may be open, compromising sterility. The recall affects 433 5-packs distributed in the US, territories, Japan, and Canada.
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: FDA Class II recall of a medical device with compromised sterility, representing a risk-of-harm product where injury has not yet been reported. No adverse events, hospitalizations, or fatalities are mentioned in the source material.
Plain-English summary
Boston Scientific Corporation is recalling ROTAWIRE Drive and wireClip Torquer, and ROTAWIRE Drive Floppy guide wire devices because pouch seals may be open, compromising the sterility of the products. These medical devices are supplied in 5-packs.
The recall affects 433 5-packs distributed in the United States and its territories, Japan, and Canada. Affected products can be identified by batch numbers 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019, 27756205, 27756933, and 27756935. The GTIN is 08714729996255.
Healthcare facilities and individuals who have received these devices should verify whether they have the affected batch numbers. Boston Scientific Corporation is responsible for managing this recall.
The recalled product
- Product
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
- Manufacturer
- Boston Scientific Corporation
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 (12)
- ROTAWIRE Drive Floppy
- 5 pack
- UPN: H74939462005 Individual units within 5-pack are labeled as Single
- UPN: H74939462001 Batch numbers: 27622475
- 27622478
- 27691111
- 27698472
- 27706785
- 27708190
- 27756019 27756205
- 27756933
- and 27756935 GTIN: 08714729996255
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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