Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Co
FDA device recall Z-1441-05 · posted 2005-08-30 · Terminated
Recall details
- Recalling firm
- Guidant Corporation
- Reason for recall
- A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
- Action taken
- By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 710
- Distribution
- nationwide and worldwide.
- Date initiated
- 2005-06-13
- Date posted
- 2005-08-30
- Date terminated
- 2007-01-05
- Location
- Saint Paul, MN
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