Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contains one tunneler and fo
FDA device recall Z-1442-05 · 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
- 278
- 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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