Recall Z-1102-06 ยท DQY Catheter, Percutaneous
Boston Scientific
Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.
| Date | Jun 10, 2006 (initiated May 22, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 75 |
| Distribution | Nationwide- States of AZ, CA, CO, FL, HI, KS, MI, NV, OK, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc., Feb 19, 1998 |