Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.
This recall has been terminated (originally issued June 10, 2006).
- Company
- Boston Scientific
- Recall Initiated
- May 22, 2006
- Posted
- June 10, 2006
- Terminated
- December 30, 2006
- Recall Number
- Z-1102-06
- Quantity
- 75
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.
Distribution
Nationwide- States of AZ, CA, CO, FL, HI, KS, MI, NV, OK, TX, VA.
Lot / Code Info
Catalog number 19500-448, Lot # 655713; Catalog number 19500-498, Lot # 655721; Catalog number 19500-08, Lot # 657310; Catalog number 19500-09, Lot # 657311; Catalog number 19500-132, Lot # 655680; Catalog number 19500-27, Lot # 655695;
Root Cause
Other
Action Taken
Affected customers were mailed an Urgent Medical Device Recall or Correction - Immediate Action Required letter, dated 05/22/2006. The letter describes the issue, states to immediately discontinue use of and segregate recalled product, provides instructions to ship product back to Boston Scientific and asks for the Reply Verification Tracking Form to be faxed to Boston Scientific in acknowledgement.