Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc
FDA device recall Z-1102-06 · posted 2006-06-10 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 75
- Distribution
- Nationwide- States of AZ, CA, CO, FL, HI, KS, MI, NV, OK, TX, VA.
- Date initiated
- 2006-05-22
- Date posted
- 2006-06-10
- Date terminated
- 2006-12-30
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER (K974684) | Scimed Life Systems, Inc. | 1998-02-19 |