FDA Medical Device Recalls (openFDA)
Abbott Vascular-Cardiac Therapies dba Guidant Corporation: Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
- Recall number
- Z-1211-2007
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Product
- Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
- Status
- Terminated
- Initiated
- 2007-07-16
- Posted
- 2007-08-29
- Terminated
- 2011-06-14
- Reason
- The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.
- Root cause
- Other
- Action
- The firm initiated the recall on 07/16/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions to work with their local account representative to review their inventory, remove the recalled product, complete the Customer Reply form and return the recalled product to Abbott Vascular.
- Quantity
- 43 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Part number 1007848-15, lot number 7052951
- 510(k) numbers
- not on file
- PMA numbers
- ["P020047"]
- Product code
- MAF
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28