Guidant Corporation Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc syringe. Sterile EO. Manufacturer Oscor Inc. 3816 DeSoto Boulevard, Palm Harbor, FL 34683. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Models 6089, 6091, 6092, 6093, 6094, 6663 and 6664. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc syringe. Sterile EO. Manufacturer Oscor Inc. 3816 DeSoto Boulevard, Palm Harbor, FL 34683. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Models 6089, 6091, 6092, 6093, 6094, 6663 and 6664.
Brand
Guidant Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
model 6089 lot numbers: C4-03103 thru C4-03707. model 6091 lot numbers: C4-03601 thru C4-03691. model 6092 lot numbers: C4-03110 thru C4-03684. model 6093 lot numbers: C4-03136 thru C4-03607. model 6094 lot numbers: C4-03501 thru C4-03610. model 6663 lot numbers: C4-03055 thru C4-03741. model 6663 lot numbers: C4-03280 thru C4-03445.
Guidant Corporation is recalling Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 due to A manufacturer of Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath duri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A manufacturer of Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026