Biosense Webster Recalls PentaRay Nav Catheters Due to Tip Separation Risk
Biosense Webster is recalling PentaRay Nav and PentaRay Nav ECO catheters because the distal tip may separate from the shaft.
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 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 recall is classified as FDA Class II and involves a structural defect (tip separation) in a cardiac device, which poses a significant risk of injury during use.
Plain-English summary
Biosense Webster, Inc. is recalling the PentaRay Nav High-Density Mapping Catheter and PentaRay Nav ECO Catheter. The recall was expanded on May 1, 2014, to include all lots of these devices. The affected catalog numbers are D128201, D128202, D128204, D128205, D128207, D128208, D128210, and D128211.
The recall is being conducted because the devices have the potential for partial tip separation from the catheter shaft. This issue is caused by an insufficient bond of the distal tip to the catheter shaft. The PentaRay Nav High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, specifically for recording or stimulation only to obtain electrograms in the atrial and ventricular regions.
A total of 15,672 units are affected, with 12,804 units distributed in the United States. The distribution pattern is US Nationwide. Healthcare providers and facilities should stop using these devices and contact Biosense Webster for further instructions.
The recalled product
- Product
- PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode…
- Manufacturer
- Biosense Webster, Inc.
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)
- Lot Numbers: All Lots
Distribution
Distributed nationwide across the United States.
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