Biosense Webster Recalls WaveCrest Left Atrial Appendage Occlusion System Devices
Biosense Webster is recalling 25 units of the WaveCrest Left Atrial Appendage Occlusion System (32 mm) because the delivery sheath may buckle during recapture.
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 classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Biosense Webster, Inc. is recalling 25 units of the WaveCrest Left Atrial Appendage (LAA) Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523. The recall covers all lots of these specific catalog numbers.
The recall was initiated because the tip of the delivery sheath may fold or buckle when attempting to recapture the 32-mm device. This mechanical issue can result in increased retraction force and difficulty or failure to recapture the device.
According to the source text, there was no U.S. distribution for these units; the distribution was international only. No specific dates, lot numbers, or injury reports are provided in the source text.
The recalled product
- Product
- WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
- Manufacturer
- Biosense Webster, Inc.
- Category
- Medical Device — Cardiac Device
- Hazard
- Affected units
- 25
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 (1)
- All lots.
Distribution
Distribution scope not specified by the agency.
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