Biosense Webster MobiCath Bi-Directional Guiding Sheath Recalled for Catheter Interaction
Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths due to a potential interaction with therapeutic catheters that may cause them to self-advance.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Greatbatch Medical is recalling 9,040 units of the Biosense Webster MobiCath Bi-Directional Guiding Sheath, catalog numbers D140010 (Small Curve) and D140011 (Large Curve). The device is a flexible tipped percutaneous catheter introducer designed for gaining access to the coronary systems and introducing cardiovascular catheters into the heart.
The recall was initiated after the company became aware of a potential interaction between therapeutic catheters and the MobiCath Bi-Directional Guiding Sheaths. This issue was identified while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths.
The affected units were distributed nationwide, specifically to California. The recall covers specific lot numbers, including W2046680, W2046681, and W2072907, among others. Healthcare providers and facilities should stop using the affected devices and contact Greatbatch Medical for further instructions.
The recalled product
- Product
- Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the cor
- Manufacturer
- Greatbatch Medical
- Affected units
- 9,040
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)
- Lot no.: W2046680
- W2046681
- W2072907
- W2078460
- W2084872
- W2098770
- W2098771
- W2102124
- W2102128
- W2102133
- W2102134
- W2108295
- W2108296
- W2108298
- W2108299
- W2108300
- W2125688
- W2125690
- W2132584
- W2132588
Distribution
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