Boston Scientific Recalls RotaWire Elite Guidewires Due to Wire Fracture Complaints
Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices because of complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire…"
Plain-English summary
Boston Scientific Corporation is recalling its RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device. These products are used in conjunction with the Rotablator Rotational Atherectomy System, which is designed for plaque modification and debulking in vascular interventions. The recall involves 955 single units, including 191 5-packs.
The recall was initiated due to complaints of wire fracture. The affected lots are 18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 18362094, 18378161, 18379210, and 18384443. The products were distributed worldwide, including in specific US states and countries such as Belgium, Germany, Great Britain, Italy, Japan, and South Africa.
Healthcare providers and patients should stop using the affected devices and contact Boston Scientific for further instructions. The source text does not report any specific injuries or illnesses associated with the wire fractures.
The recalled product
- Product
- RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation…
- 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 (10)
- Lots: 18201519
- 18212726
- 18256610
- 18261218
- 18271412
- 18282032
- 18362094
- 18378161
- 18379210
- 18384443
Distribution
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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