Biosense Webster MobiCath Guiding Sheath Recalled for Unsealed Pouch
Greatbatch Medical is recalling 11,360 MobiCath Bi-Directional Guiding Sheaths because one side of the pouch may not be sealed.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a packaging seal issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Greatbatch Medical is recalling 11,360 units of the Biosense Webster MobiCath Bi-Directional Guiding Sheath, Models D140010 and D140011. The recall is due to a manufacturing defect where one side of the device pouch may not be sealed. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer designed for gaining access to the coronary systems.
The affected units were distributed in California. The recall includes specific lot numbers for both the small curve (Model D140010) and large curve (Model D140011) versions of the device. The device features adjustable tip geometry and is assembled with a hemostasis valve and a sideport infusion line.
Healthcare providers and facilities should check their inventory for the affected model numbers and lot codes. If the device is found, it should be removed from use and returned to Greatbatch Medical according to the recall instructions.
The recalled product
- Product
- Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary…
- Manufacturer
- Greatbatch Medical
- Affected units
- 11,360
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 (20)
- Model D140010
- Lots: W3332609
- W3338632
- W3338635
- W3338707
- W3348350
- W3348351
- W3352503
- W3359665
- W3363850
- W3363851
- W3370052
- W3374699
- W3374700
- W3379647
- W3379650
- W3384700
- W3384701
- W3390549
- W3390551
Distribution
Distributed in 1 state:
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