Reported Aug 9, 2017 · Terminated
Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The…
Greatbatch Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Greatbatch Medical · 2300 Berkshire Ln N · Plymouth, MN · 55441-4575
Is this the product you have?
- 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 systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.
- Lot codes and dates
- Model D140010
- Lots
62 of 62 codes
W3332609W3338632W3338635W3338707W3348350W3348351W3352503W3359665W3363850W3363851W3370052W3374699W3374700W3379647W3379650W3384700W3384701W3390549W3390551W3397877W3397879W3397950W3407814W3407815W3436351W3436355W3436356W3436358W3441735W3441737W3446767W3446769W3449392W3451862W3451863W3455438W3455439W3455440W3459354W3462467W3462470W3470335W3470336W3483637W3493240W3497507W3501348W3501349W3581648X3489776X3497121X3497510X3501344X3501345X3503248X3507599X3514814X3518116X3565743X3581652
- Lots—
- Amount recalled
- 11,360
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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